Clinical Trials

Enrollment Complete for PRESERVE 1 Trial of Trilaciclib in Metastatic Colorectal Cancer

June 17th 2022

Enrollment has been completed for the phase 3 PRESERVE 1 trial of trilaciclib in patients with metastatic colorectal cancer receiving chemotherapy.

Datopotamab Deruxtecan Treatment in TROPION-Breast02 Trial Begins in mTNBC Population

June 14th 2022

On the heels of positive phase 1 data, the phase 3 TROPION-Breast02 clinical trial has begun dosing of datopotamab deruxtecan in select patients with metastatic triple-negative breast cancer.

Golidocitnib Shows Promising Anti-Tumor Activity, Safety in PTCL

June 11th 2022

Results from JACKPOT8 presented during the 2022 EHA Congress show that golidocitnib has encouraging anti-tumor efficacy and tolerable safety in patients with relapsed or refractory peripheral T-cell lymphoma.

First Patient Dosed in Phase 1 Study of YL-13027 for Advanced Solid Tumors

June 10th 2022

YL-13027 has been dosed for the first time in a patient with advanced solid tumors.

Initial Data of CB-010 in Relapsed/Refractory B-Cell NHL Reported at EHA 2022

June 10th 2022

Data from ANTLER presented during the 2022 EHA Congress show initial findings of CB-010 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Adjuvant Pembrolizumab Plus Belzutifan in ccRCC

June 2nd 2022

Toni K. Choueiri, MD, discusses the design of the phase 3 LITESPARK-022 study, which investigates adjuvant pembrolizumab in patients with clear cell renal cell carcinoma.

NX-2127 Treatment Starts in Patients With R/R Chronic Lymphocytic Leukemia

May 26th 2022

Dosing of NX-2127 in patients with chronic lymphocytic leukemia has begun in a phase 1b clinical trial.

FDA Lifts Partial Clinical Hold on NEON-2 Evaluating Davoceticept/Pembrolizumab in Advanced Cancers

May 26th 2022

The FDA has lifted the partial clinical hold on the phase 1 NEON-2 trial of davoceticept plus pembrolizumab in adult patients with advanced solid tumors or lymphoma.

Investigators Hope Oregovomab Combo Will Show Benefit in Advanced Epithelial Ovarian Cancer

May 19th 2022

A new murine monoclonal antibody B43.12 is under investigation in combination with paclitaxel and carboplatin as a treatment option for patients with advanced epithelial ovarian cancer.

First Patient Dosed in IMAGINE Trial Evaluating MT-101 in Patients With PTCL

May 13th 2022

Investigators of the phase 1/2 IMAGINE study, evaluating MT-101 in patients with refractory or relapsed peripheral T-cell lymphoma, have dosed its first patient.

Study of ATL001 Plus ICI Therapy Now Enrolling Patients with Metastatic Melanoma

May 9th 2022

The phase 1/2 THETIS clinical trial is actively recruiting patients with metastatic melanoma to be treated with the investigation combination of ATL001 and an immune checkpoint inhibitor.

Phase 2 Trial of GT90001 Plus Nivolumab Enrolls First Patient With Advanced HCC

May 8th 2022

The phase 2 clinical trial of the combination therapy, GT90001 and nivolumab, for the treatment of patients with advanced hepatocellular carcinoma has dosed its first patient.

PROPHETIC Study Will Evaluate Response to I/O Therapy in Patients With Cancer Using a Diagnostic Platform

May 4th 2022

Florida Cancer Specialists & Research Institute sites and site worldwide are now recruiting patients for the PROPHETIC study.

PACIFIC-9 Starts Dosing Durvalumab With Monalizumab or Oleclumab in Patients With Unresectable NSCLC

May 4th 2022

As a follow-up to the success observed in the phase 2 COAST study, investigators of the phase 3 PACIFIC-9 have begun administering durvalumab in combination with monalizumab or oleclumab to patients with unresectable, stage III non–small cell lung cancer.

Trials Initiated to Evaluate SRF388 Monoclonal Antibody in HCC and NSCLC

May 2nd 2022

Surface Oncology announced the initiation of new trials of the investigational agent SRF388 in patients with hepatocellular carcinoma and non–small cell lung cancer.

Trial of Odetiglucan Plus Pembrolizumab for Metastatic Breast Cancer Starts Dosing

April 29th 2022

Treatment with the combination of odetiglucan or Imprime PGG and pembrolizumab had begun in patients with metastatic hormone-refractory breast cancer who are enrolled in a phase 2 clinical trial.

Pivotal Study of Zanidatamab for HER2-Expressing Biliary Tract Cancer Now Fully Enrolled

April 29th 2022

The phase 2 HERIZON-BTC-01 of zanidatamab in patients with HER2-amplified biliary tract cancer has met its patient enrollment goal.

FDA Grants Fast Tracks SQZ-PBMC-HPV for HPV16+ Advanced/Metastatic Solid Tumors

April 28th 2022

The FDA has granted fast track designation to SQZ-PBMC-HPV for the treatment of patient with HPV16-positive advanced or metastatic solids tumors, according to an announcement by SQZ Biotechnologies.

Global ZILO-301 Study of Zilovertamab for MCL to Initiate in Q3 2022

April 28th 2022

Oncternal Therapeutics announced it would terminate its study of ONCT-216 for patients with Ewing sarcoma and prioritize its phase 3 ZILO-301 study of zilovertamab plus ibrutinib for patients with relapsed/refractory mantle cell lymphoma.

Design of the ANAPLAST-NEO Study for Anaplastic Thyroid Cancer

April 28th 2022

Yuliya Mikheeva, MD, PhD, discusses the design of the phase 2 ANAPLAST-NEO study

FDA Grants ODD Status to TTI-101 for Hepatocellular Carcinoma

April 25th 2022

The FDA has granted orphan drug designation to the STA3 inhibitor, TTI-101, for the treatment of hepatocellular carcinoma. The agent is currently being investigated in a phase 1 clinical trial.

PT-112 Treatment for Thymoma and Thymic Carcinoma Starts in a Phase 2 Study

April 18th 2022

Treatment with PT-112 has begun in a phase 2 study of patients with thymoma and thymic carcinoma.

NEBULA Trial Looks to Overcome Immunosuppressive TME in Epithelial Tumors

April 12th 2022

The phase 1a/b NEBULA trial is investigating the safety and preliminary efficacy of the adenoviral vector NG-641 in combination with nivolumab in patients with previously treated metastatic or advanced epithelial tumors.

FDA Allows Magrolimab Studies to Continue in Patients With MDS and AML

April 12th 2022

Magrolimab clinical trials including patients with myelodysplastic syndrome and acute myeloid leukemia may continue now that the FDA has lifted a partial clinical hold.

TakeAim Lymphoma Study Evaluating Emavusertib Pauses Enrollment of Patients With B-cell Malignancies

April 11th 2022

With a voluntary partial clinical hold in place, patients who were already enrolled to the TakeAim Lymphoma study and deriving benefit from emavusertib can continue treatment at the dose of 300 mg twice daily or lower.

Combining Novel PARP7 Inhibitor With Pembrolizumab to Treat SCCL

April 4th 2022

The combination of RBN-2397 and pembrolizumab has been dosed in the first patient with squamous cell carcinoma of the lung who is enrolled in a new phase 1b/2 clinical trial.

PP2A Inhibitions May Address Transformation of NSCLC to SCLC in Patients With EGFR+ Disease

March 29th 2022

In an interview with Targeted Oncology, Ravi Salgia, MD, PhD, discussed the research leading to the first-in-human study of LB-100 combined with chemotherapy or immunotherapy to address transformation to small cell lung cancer.

Phase 1b/2 Study To Evaluate AUTO1 CAR T Cells in Relapsed/Refractory Adult B-Cell ALL

March 29th 2022

Treatment with AUTO1, an investigational CD19-targeted chimeric antigen receptor T-cell therapy, is being evaluated in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

EMERGE-201 Explores Lurbinectedin for Treatment of Select Advanced/Metastatic Solid Tumors

March 28th 2022

The phase 3 EMERGE-201 for patients with advanced urothelial carcinoma, large cell neuroendocrine carcinoma of the lung, or homologous recombination deficient has begun.

Advancing Real-World Data to Improve Oncology Care

March 25th 2022

In an interview with Targeted Oncology, C.K. Wang, MD, discussed the importance of real-world data in oncology, the mission of COTA, and research the company has been a part of.

PACIFICA Investigates Pacritinib’s Ability to Reduce Spleen Volume in Myelofibrosis

March 17th 2022

Following PERSIST-1 and PERSIST-2 and a recent FDA approval, pacritinib is being investigated in a phase 3 study versus physician's choice of standard therapy in patients with myelofibrosis.

PIVOT IO-001 Enrollment Stops After Trial Failure, But Analyses Continue

March 15th 2022

In PIVOT IO-001, patients with metastatic melanoma are no longer being enrolled and treatment arms have been unblinded after the combination of bempegaldesleukin and nivolumab did not meet its coprimary end points.

BESPOKE CRC Halfway to Enrollment Goal of Patients With Stage I-IV Resectable CRC

March 14th 2022

The developer has announced that half of the patients are now enrolled in the BESPOKE CRC clinical trial.

PY314 Treatment Begins in Phase 1B Study of Patients With Advanced Solid Tumors

March 12th 2022

The first patient has received PY314 in a phase 1b study, and patients with advanced solid tumor are being actively recruited as sites across the United States.

Treatment With Evorpacept Combination Initiates in ASPEN-06 Study for Gastric/GEJ Cancer

March 10th 2022

Following positive early results from the ASPEN-01 clinical trial, the first patient with HER2-positve gastric or gastroesophageal cancer has received the experimental combination of evorpacept, trastuzumab, ramucirumab, and paclitaxel in ASPEN-06.

FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma

March 9th 2022

Fast track designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.

Phase 3 EQUATOR Study to Initiate Itolizumab Treatment in Patients With aGVHD

March 9th 2022

The phase 3 EQUATOR clinical trial has been initiated in the United States for the treatment of patients with acute graft-versus-host disease.

FDA Grants Orphan Drug Status to Epcoritamab for Follicular Lymphoma Treatment

March 9th 2022

Epcoritamab had been granted orphan drug designation by the FDA for the treatment of follicular lymphoma and is being studied in a phase 1/2 clinical trial.

Batiraxcept/Cabozantinib Shows Positive Efficacy in Patients With ccRCC

March 8th 2022

Updated data from the ongoing phase 1b/2 trial of batiraxcept in combination with cabozantinib shows favorable outcomes in patients with clear cell renal cell carcinoma.

Dosing Begins in Phase 1/2 Study of Reqorsa Plus Osimertinib in Advanced NSCLC

March 7th 2022

Dosing has begun in patients with advanced non–small cell lung cancer in the phase 1/2 Acclaim-1 clinical trial of quaratusugene ozeplasmid in combination with osimertinib after disease progression on osimertinib alone.

FDA Grants Orphan Drug Designation to TJ-CD4B for Gastric Cancer

March 3rd 2022

TJ-CD4B had been granted orphan drug designation by the FDA for the treatment of patients with gastric cancer, including gastroesophageal junction carcinoma.

DKN-01 Offers a Solution to Modest IO Benefit in Advanced Gastroesophageal Carcinoma

March 2nd 2022

In an interview with Targeted Oncology™, Samuel K. Klempner, MD, discussed the promise of DKN-01 and early results from the DisTinGuish trial.

MARIPOSA Trial to Examine How Amivantamab Plus Lazertinib Compares With Osimertinib in EGFR+ NSCLC

February 24th 2022

The MARIPOSA study seeks to assess efficacy, safety, and pharmacokinetics of the combination of amivantamab-vmjw and lazertinib in locally advanced, or metastatic non-small cell lung cancer.

FDA Approves Pembrolizumab CDx for MSI-H Solid Tumors

February 23rd 2022

The FDA has approved FoundationOne CDx as a companion diagnostic to pembrolizumab for patients with microsatellite instability high solid tumors.

ZB131 Treatment Begins in Patients With Advanced Solid Tumors

February 22nd 2022

A new study is looking into the safety, tolerability, and preliminary efficacy of ZB131 in patients with advanced solid tumors.

FDA Grants Fast Track Status to IO-202 for Relapsed/Refractory AML

February 18th 2022

IO-202 for the treatment of patients with relapsed or refractory acute myeloid leukemia is a strategy under investigation in a phase 1, multicenter, open-label, dose-escalation and expansion study.

FDA Grants Orphan Drug Designation For CT103A in R/R Myeloma

February 14th 2022

CT103A is a BCMA-targeted genetically modified autologous T cell immunotherapy that is able to identify and eliminate malignant and normal cells expressing BCMA in R/R Myeloma.

Early Studies Investigate Novel IO Strategy in Merkel Cell Carcinoma and Glioblastoma

February 14th 2022

Treatment with multiple nucleic acid immunotherapy agents is being evaluated in phase 1/2 clinical trials.

Gene Therapy Shows Encouraging Clinical Efficacy/Safety in BCG-Unresponsive NMIBC

February 11th 2022

A novel gene therapy is being investigated for the treatment of Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer, and the preliminary findings signal a high response rate with little toxicity.

PRIMO Study for R/R Peripheral T-cell Lymphoma Meets Enrollment Milestone

February 10th 2022

After a successful interim analysis, the PRIMO study of duvelisib for the treatment of relapsed or refractory peripheral T-cell lymphoma is now fully accrued.

Dosing of Efineptakin Alfa/Atezolizumab Begins in Study of Patients With Advanced Skin Cancer

February 9th 2022

A patient with a high-risk skin cancer has been administered an investigational interleukin 7 agent, efineptakin alfa, plus atezolizumab, initiating treatment in a phase 2a study.

Phase 2B Study Explores I/O Vaccine for Treatment of Newly Diagnosed Glioblastoma Patients

February 8th 2022

After treatment with SurVaxM in patients with newly diagnosed glioblastoma significantly improved survival, investigators are continuing the evaluation of the agent in a phase 2b clinical trial.

ViPOR Regimen Signals Benefit in Patients With Mantle Cell Lymphoma

February 7th 2022

In an interview with Targeted Oncology, Christopher Melani, MD, discussed the ongoing ViPOR study exploring a Bruton’s tyrosine kinase inhibitor and BCL2 inhibitor, and NF-κB survival pathway activating combination.

Florida Cancer Specialists Physician Studies Featured at American Society of Clinical Oncology 2022 Gastrointestinal Cancers Symposium

February 2nd 2022

FCS is the leading community-based oncology practice in Florida with clinical trial opportunities made available to patients at 36 locations in the state.

Advancing Therapies for Patients Through Clinical Research in Community Oncology Practices

February 2nd 2022

The survival rate for Americans diagnosed with several of the most common cancers has increased dramatically in the past nearly three decades, thanks in large part to scientific discoveries and treatment advances.

Efficacy/Safety Evaluation of Selpercatinib in RET-Driven MTC Ongoing in LIBRETTO-531

January 24th 2022

LIBRETTO-531 succeeds LIBRETTO-001 to continue the study of selpercatinib in patients with multikinase inhibitor therapy-naive RET-mutant advanced medullary thyroid cancer.

Will Momelotinib Phase 3 Study Show TSS Reduction in Patients With Myelofibrosis?

January 24th 2022

Results from the ongoing phase 3 MOMENTUM clinical trial may be available by the end of Janaury 2022.

Phase 3 Trial to Determine the Potential Superiority of Pembrolizumab/Lenvatinib vs Chemotherapy in Advanced Endometrial Cancer

January 21st 2022

Pending results from the ENGOT-en9/LEAP-001 will determine whether the combination of pembrolizumab and lenvatinib prolongs survival more than chemotherapy in patients with endometrial cancer.

Cinrebafusp Alfa Combinations Explored in HER2-Expressing Gastric Cancer

January 18th 2022

A study of cinrebafusp alfa is underway to evaluate its safety and efficacy in combination with other therapies in patients with gastric or gastroesophageal junction cancers.

Study Explores Neoantigen Vaccine With Immune Checkpoint Blockade in Metastatic MSS-CRC

January 17th 2022

The phase 2/3 GRANITE-CRC-1L clinical trial has been initiated.

VITALIZE to Validate the Efficacy/Safety of Maveropepimut-S Plus Pembrolizumab for R/R DLBCL

January 13th 2022

A phase 2b study aims to confirm positive efficacy and safety results previously reported with the combination of maveropepimut-S and pembrolizumab in patients with relapsed or refractory diffuse large B-cell lymphoma.

Does the Addition of Cabozantinib to Atezolizumab Improve Survival in Advanced RCC?

January 11th 2022

The target number of patients with advanced renal cell carcinoma has been enrolled in the phase 3 CONTACT-3 trial, which aims to determine the efficacy and safety of cabozantinib combined with atezolizumab.

FDA Grants Fast Track Designation to Novel AR Inhibitor for AR+/ER+/HER- mBC

January 10th 2022

Enobosarm has been granted fast track designation from the FDA and is being explored alone and in combination with abemaciclib in 2 phase 3 clinical trials.

Novel IRAK4 Inhibitor Demonstrates Clinical Efficacy, Acceptable Safety in AML and MDS

January 8th 2022

CA-4948 was found to have a complete remission rate of 40% and an objective response rate of 57% in some patients with acute myeloid leukemia and myelodysplastic syndrome.

New Study Explores EBNA1 as a Target for Epstein-Barr Virus-Positive Advanced Nasopharyngeal Carcinoma

January 7th 2022

A phase 2 study is preparing to enroll patients with Epstein-Barr virus-positive advanced nasopharyngeal carcinoma, who will be treated with an investigational EBNA1 inhibitor.

FDA Okays Phase 3 Study of Zilovertamab in R/R Mantle Cell Lymphoma

January 6th 2022

A study of zilovertamab in combination with ibrutinib for the treatment of relapsed or refractory mantle cell lymphoma will be launched in the second quarter of 2022.

OQL011 for Hand and Foot Reaction Shows Clinical Activity, Tolerable Safety

January 4th 2022

Topline results from the phase 2 NOVA-II trial showed clinical efficacy and an acceptable safety profile with OQL011.

Benefit of Lurbinectedin to be Confirmed in Randomized, Phase 3 Clinical Trial

January 3rd 2022

Lurbinectedin is being evaluated as treatment of patients with small cell lung cancer in a phase 3 trial.

FDA Grants Fast Track Designation to CYNK-001 for AML Treatment

December 29th 2021

A novel natural killer cell therapy is now on the fast track to FDA approval and being assessed in a phase 1 clinical trial.

Phase 2 Study of Selinexor for Myelofibrosis Progresses

December 28th 2021

A phase 2 study is underway to determine the efficacy and safety of selinexor in patients with myelofibrosis.

Rationale for the Phase 3 COSMIC-313 Study in RCC

December 23rd 2021

Toni Choueiri, MD, explains what led to the phase 3 COSMIC-313 clinical trial.

SIENDO Study in Endometrial Cancer Hits Enrollment Milestone

December 15th 2021

All 248 patients with endometrial cancer have been enrolled in the phase 3 SIENDO clinical trial.

Zanidatamab With Chemotherapy Shows Early Promise in HER2-Positive Breast Cancer

December 9th 2021

Adding zanidatamab to chemotherapy may result in positive efficacy and safety outcomes in patients with HER2-positive breast cancer.

Breakthrough Device Designation Granted to ZetaMet for Metastatic Bone Lesions

December 3rd 2021

The device is meant to not only target metastatic bone lesions, but also promote the growth of healthy bone.

Phase 3 Investigation of Lurbinectedin Plus Atezolizumab Underway in ES-SCLC

December 2nd 2021

In the phase 3 IMforte clinical trial, researchers are exploring lurbinectedin and atezolizumab as induction and maintenance therapy for patients with extensive-stage small cell lung cancer.

FDA Orphan Drug Designation Granted to INBRX-109 for Chondrosarcoma

December 2nd 2021

With an orphan drug designation from the FDA, INBRX-109 may be on track to become the first FDA-approved treatment for chondrosarcoma.

Etiglimab/Nivolumab Combination Shows Promise in Solid Tumors

December 1st 2021

The combination elicited a complete response in patient with cervical cancer and a partial response in a patient with ovarian cancer.

Investigators Dose Datopotamab Deruxtecan in First Patient With HR+ /HER2- Breast Cancer

November 26th 2021

The TROPION-Breast01 study aims to enroll 700 patients to determine the safety and efficacy of datopotamab deruxtecan in patients with HR-positive, HER2-negative breast cancer.

Milademetan Treatment Begins for MDM2-Mutated Solid Tumors in Phase 2 Basket Trial

November 24th 2021

Milademetan, an MDM2-inhibitor, has already shown preliminary antitumor efficacy in solid tumors.

FDA Halts KOMET-001 Study for Acute Myeloid Leukemia Due to Safety

November 24th 2021

The phase 1b KOMET-001 has been suspended while the developer of KO-539 and FDA investigate a serious safety event.

Study of Ruxolitinib Pre and Post HSCT for Myelofibrosis Currently Recruiting

November 22nd 2021

The study is currently recruiting in 5 states and aims to determine if ruxolitinib affects GvHD rates in patients received HSCT for the treatment of myelofibrosis.

Devimistat Plus Hydroxychloroquine Trial for Soft Tissue Sarcoma Enrolls First Patient

November 15th 2021

A California-based study of devimistat plus hydroxychloroquine for soft tissue sarcoma has enrolled its first patient.

FDA Grants Orphan Drug Status to LYT-200 for Pancreatic Cancer

November 15th 2021

The FDA has granted orphan drug designation to LYT-200 for the treatment of patients with pancreatic cancer. The drug is currently under investigation in phase 1/2 clinical trial for the treatment of pancreatic cancer and other metastatic solid tumors.

Global Phase 3 Study Explores Belzutifan/Lenvatinib Doublet in Advanced RCC

November 11th 2021

The novel combination of belzutifan and lenvatinib will be tested against cabozantinib in a phase 3 clinical trial of patients with advanced renal cell carcinoma.

Study Explores Addition of HIF-2α Inhibitor or Anti-CTLA-4 Therapy to Pembrolizumab Plus Lenvatinib in ccRCC

November 8th 2021

The combination of lenvatinib and pembrolizumab is the current standard of care for ccRCC, however, most patients still experience disease progression. The addition of a third agent may lead to improvement in outcomes.

Study of Taletrectinib for ROS1-Positive NSCLC Doses First Patient

October 30th 2021

The trial is evaluating the safety and efficacy of taletrectinib in ROS1 NSCLC. Taletrectinib is a novel TKI.

Early Activity of Novel BTK Degrader Shown in Chronic Lymphocytic Leukemia

October 29th 2021

In a phase 1 dose-escalation study, an investigational BTK degrader showed clinically meaningful results in patients with chronic lymphocytic leukemia and elicited a response.

Dosing of Cleveland Clinic’s α-Lactalbumin Vaccine Begins in Phase 1 Breast Cancer Study

October 27th 2021

After discovering the potential of a prophylactic breast cancer vaccine, Cleveland Clinic will be the site of a phase 1 clinical trial to test its safety.

Trial of Novel Hypomethylating for MDS Doses First Patient

October 26th 2021

The trial is designed to evaluate eltanexor monotherapy in high-risk MDS. It is recruiting in 8 separate states.

Convenient Clinical Trial Locations, Research Staff Availability Mitigate Barriers to Trial Access, Survey Says

October 23rd 2021

Flexible patient-focused approaches may increase clinical trial accessibility and enrollment in international lung cancer clinical trials beyond the COVID-19 pandemic.

Study Underway to Evaluate New PD-1/CD3 Antibody in T-cell Lymphoma

October 21st 2021

A trial is currently recruiting across the US to investigate the safety of a new anti-PD-1/CD3 antibody for the treatment of relapsed or refractory T-cell lymphoma. It aims to enroll 86 patients.

New Option After Tisagenlecleucel for Patients With R/R LBCL Now in Development

October 20th 2021

Following treatment with chimeric antigen receptor T-cell therapy, patients with relapsed or refractory large B-cell lymphoma require more options. Investigators are now evaluating an interleukin-17 agent.

Liposomal Annamycin Shows Early Clinical Activity in Soft Tissue Sarcoma Lung Metastases

October 19th 2021

A phase 1b/2 study has shown an 80% clinical activity rate with liposomal annamycin as treatment of soft tissue sarcoma lung metastases.

Study Underway to Evaluate Ixazomib/Rituximab in R/R MCL

October 18th 2021

A study at MD Anderson Cancer Center aims to evaluate ixazomib and rituximab in patients with relapsed or refractory mantle cell lymphoma.

RP-3500 Shows Early Activity/Safety in Advanced Solid Tumors With DDR Pathway Alterations

October 12th 2021

A novel ATR inhibitor displayed early signals of activity and was tolerable in patients with solid tumor harboring various molecular alterations.

Rusfertide Clinical Trials to Resume After FDA Lifts Hold

October 12th 2021

Following a safety evaluation, the FDA has lifter its clinical hold of studies of rusfertide.

FDA Halts Development of Select Allogeneic CAR T-Cell Therapies Due to Safety Concern

October 8th 2021

All clinical trials of allogeneic CAR T cells developed by Allogene Therapeutics, Inc have been halted by the FDA pending an investigation of a chromosomal abnormality event.

Researchers Seek the Optimal Dose of Venetoclax/Azacitidine/Obinutuzumab in FL

October 8th 2021

The study is currently recruiting in Chicago, Illinois.

Investigators Combine Zanidatamab With Evorpacept to Potentially Improve Outcomes in HER2-Expressing Breast Cancer

October 7th 2021

Zanidatamab in combination with evorpacept has been dosed for the first time in a patient with HER2-low breast cancer.

ASSURE Trial to Investigate Acalabrutinib in Treatment-Naïve and R/R CLL

October 5th 2021

The ASSURE trial is actively recruiting patients with chronic lymphocytic leukemia to receive acalabrutinib in an investigation of its safety and efficacy.

Trial Enrolls Final Patient To Evlaluate Tucatinib/Trastuzumab for HER2-Positive mCRC

September 29th 2021

The last patient has been enrolled in the phase 2 MOUNTAINEER trial, evaluating tucatinib both as a monotherapy and in combination with trastuzumab for the treatment of HER2-positive metastatic colorectal cancer following previous first- and second-line standard of care therapies.

Exploring Asciminib Monotherapy in CML-CP +/- T315I Mutations

September 29th 2021

Moshe Levy, MD discusses the ongoing phase 3b study of asciminib in patients with chronic myeloid leukemia in chronic phase.

BRAF/MEK Inhibitor Combination Shows Promise in Anaplastic Thyroid Cancer

September 28th 2021

Principle study investigator Yuliya Mikheeva, MD, PhD, of Saint-Petersburg State University, discussed the combination of dabrafenib and trametinib for the treatment of anaplastic thyroid cancer in an interview with Targeted Oncology.

Devimistat Now Being Explored for the Treatment of Clear Cell Sarcomas in the United States

September 27th 2021

Following its success in acute myeloid leukemia and other cancers, devimistat is being explored as a treatment option for clear cell sarcoma in a phase 1/2 trial.

Clinical Trial Explores New FRα-Targeting ADC for Platinum-Resistant Ovarian Cancer

September 10th 2021

In an interview with Targeted Oncology, John Diaz, MD, discussed the ovarian cancer treatment paradigm and the promise of STRO-002 for an important ovarian cancer subgroup.

Investigators Initiate Treatment With ERAS-007 in Patients With EGFR-Positive NSCLC

September 10th 2021

The first patient has been dosed in the phase 1b/2 trial of ERAS-007, an extracellular signal-regulated kinase inhibitor, for the treatment of advanced non-small cell lung cancer.

Buparlisib Treatment Begins in Combination With AN0025 and Atezolizumab for Advanced Solid Tumors

September 9th 2021

The first patient with a locally advanced or metastatic solid tumor has been dosed with buparlisib in combination with A0025 with or without atezolizumab in a phase 1a clinical trial.

NOVA-II Study Completes Analysis of Treatment for Cancer Therapy-Induced Skin Toxicities

September 7th 2021

The phase 2 NOVA-II study has completed its part 1 analysis of OQL011 for the treatment of cancer therapy-induced skin toxicities.

Determining the Outcomes of TTI-622 With Azacitidine for TP53-Mutant AML

September 6th 2021

Cancer research sites across the United States are evaluating the use of TTI-622 plus azacitidine in patients with T53-mutated acute myeloid leukemia.

First Patients Dosed in New CA125 Antagonist Study in Ovarian Cancer

September 2nd 2021

Two international studies of oregovomab in combination with other anticancer therapies for the treatment of previously treated, recurrent ovarian cancer have dose its first patients, and patients are being recruited to receive the drug in a phase 3 study conducted in the United States.

Adjuvant Giredestrant Goes Up Against Third-Generation Endocrine Therapies in ER+/HER2- Early Breast Cancer

September 1st 2021

Adjuvant giredestrant is being evaluated in comparison with other endocrine therapies for the treatment of ER-positive, HER2-negative, early breast cancer.

Devimistat With Gemcitabine and Cisplatin Advances to Phase 2 in Biliary Tract Cancer

August 30th 2021

Following the successful completion of the phase 1b analysis, the study of devimistat in combination with gemcitabine and cisplatin in biliary tract cancer has moved on to phase 2.

Study Explores Sacituzumab Goveitecan Versus SOC in Metastatic or Locally Advanced Unresectable UC

August 30th 2021

Sacituzumab goveitecan has been administered to the first time in a patient with metastatic or locally advanced unresectable urothelial carcinoma as part of the phase TROPICS-04 study.

Treatment With FHD-609 Begins in Phase 1 Synovial Sarcoma Study

August 23rd 2021

The first patient has been dosed in a trial of FHD-609, a selective protein degrader of bromodomain-containing protein 9, for the treatment of synovial sarcoma.

Investigation Continues for Highly Potent Antibody-Drug Conjugate in HER2-Expressing Solid Tumors

August 20th 2021

Oncologists treating patients with HER2-expressing solid tumors can now refer patients for enrollment in a phase 2 trial of the novel drug A166, that has shown high potency in these tumors.

Can Zandelisib Combination Offer a Chemotherapy-Free Option for iNHL?

August 19th 2021

Three centers in the United States are recruiting patients with indolent non-Hodgkin lymphoma to receive the investigational selective PI3Kδ inhibitor zandelisib in combination with rituximab in a phase 3 clinical trial setting. The study aims to determine the efficacy and safety of zandelisib in combination with rituximab compared with standard immunochemotherapy.

Head-To-Head Phase 3 Trial To Evaluate BTK Inhibitors in MCL

August 17th 2021

Inhibition of the Bruton’s tyrosine kinase (BTK) has shown potency in B-cell malignancies, leading to the exploration of treatment with the BTK inhibitor LOXO-305 in patients with mantle cell lymphoma (MCL) in the phase 3 BRUIN clinical trial.

DUO-E Trial Explores 1L Durvalumab Maintenance With or Without Olaparib in Advanced/Recurrent Endometrial Cancer

August 15th 2021

In an interview with Targeted Oncology™, Shannon N. Westin, MD, MPH, FACOG, discussed the need for the DUO-E trial in the endometrial cancer space and the unique patient population the study will evaluate.

First Patient Dosed in AVB-500 Trial For Pancreatic Adenocarcinoma

August 13th 2021

The first patient has been dosed in a phase 1b/2 trial of AVB-500, a therapeutic recombinant fusion protein, in combination with gemcitabine and nab-paclitaxel for the treatment of advanced pancreatic adenocarcinoma.

Zandelisib Moves Along in Development for B- Cell Malignancies

August 12th 2021

The first patient with marginal zone lymphoma has been dosed in the global phase 2 TIDAL study of zandelisib, a phosphatidylinositol 3-kinase (PI3K) delta inhibitor, for the treatment of MZL and follicular lymphoma in patients who have received at least 2 or more prior therapies.

KISIMA-01 Investigates the Safety of ATP128 With or Without Ezabenlimab in CRC

August 12th 2021

Scott Kopetz, MD, PhD, FACP, explains the purpose of the phase 1b KISIMA-01 study of the ATP128 vaccine used with or without with or without ezabenlimab to treat patients with advanced colorectal cancer.

Global Study Explores RAF/MEK/FAK Combo in Recurrent LGSOC, With or Without KRAS Mutations

August 6th 2021

In an interview with Targeted Oncology™ following a presentation of the study protocol at the 2021 American Society of Clinical Oncology Annual Meeting, Susana K. Banerjee, PhD, explained the progress of ENGOT-ov60/GOG3052/RAMP 201 in detail.

Trial of ARX517 Doses First Patient With a PSMA-Expressing Solid Tumor

August 5th 2021

To address over expression of the prostate specific membrane antigen in men with prostate cancer and other solid tumors, a phase 1 study of the novel anti-PSMA antibody drug conjugate, ARX517, has been administered to the first patient.

Exploration of WEE-1 Inhibition in Recurrent/Persistent Uterine Serous Carcinoma Continues to Phase 2

August 4th 2021

Following the success of a phase 1 study that showed its potential for accelerated FDA approval in the future, the WEE-1 inhibitor, ZN-c3 has been dosed for the first time in the newly launched phase 2 study, which is exploring the agent for the treatment of adult women with recurrent or persistent uterine serous carcinoma.

Trial Aims to Determine Efficacy of Radiotherapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER+ Breast Cancer With LMD

August 4th 2021

In an interview with Targeted Oncology™, Kamran A. Ahmed, MD, discussed the novel treatment strategy of combining radiotherapy with intrathecal trastuzumab/pertuzumab as well as and the rationale behind the combination.

Impact on Survival of Durvalumab +/- Olaparib Investigated in Endometrial Cancer

July 30th 2021

In an interview with Targeted Oncology™, Shannon N. Westin, MD, MPH, FACOG, discussed the DUO-E trial, its design, end points, and the need for novel endometrial cancer therapies. 

FDA Warns of Death Risk in Ongoing Multiple Myeloma Clinical Trial

July 29th 2021

A warning from the FDA highlights that an increased rate of death has been observed in patients with multiple myeloma who are undergoing treatment with the FDA-approved agent melphalan flufenamide in combination with dexamethasone in the phase 2 OCEAN clinical trial.

Study Evaluates Addition of Selinexor to Ruxolitinib in Patients With Treatment-Naïve Myelofibrosis

July 29th 2021

Selinexor has been administered in combination with ruxolitinib to the first patient with treatment-naïve myelofibrosis as part of a phase 1/2 clinical trial.

Study Explores Anti-PVRIG Therapy Plus Nivolumab and Anti-TIGIT Therapy in Advanced Solid Tumors

July 28th 2021

The first patient with an advanced solid tumor has been dosed with the first-in-class anti-PVRIG antibody, COM701, in combination with nivolumab and the anti-TIGIT antibody, BMS-986207, in a phase 1/2 clinical trial.

Oral MDM2 Inhibitor Milademetan Enters Phase 3 Study for Patients with De-Differentiated Liposarcoma

July 22nd 2021

A phase 3 study has been initiated in order to evaluate the efficacy of the oral MDM2 inhibitor milademetan for the treatment of de-differentiated liposarcoma.

First Patient Dosed in LAVA-051 Hematologic Malignancy Trial

July 19th 2021

The first patient has been dosed in the phase 1/2a clinical trial, designed to evaluate LAVA-051- a gamma-delta bispecific gamma-delta T cell engager that activates Vγ9Vδ2 T cells and type 1 natural killer T cells-in those with chronic lymphocytic leukemia, multiple myeloma, and acute myeloid leukemia.

Clinical Trial of Seclidemstat for Ewing Sarcoma Adds Fox Chase Cancer Center to List of Treatment Sites

July 19th 2021

The Fox Chase Cancer Center at Temple University in Philadelphia, Pennsylvania has been added as an active trial site by Salarius Pharmaceuticals, Inc. for the ongoing trial of seclidemstat for the treatment of relapsed or refractory Ewing sarcoma and advanced FET-rearranged sarcomas.

Dual Blockade of PVRIG and TIGIT Underway in Patients With Advanced Malignancies

July 15th 2021

The investigational anti-TIGIT agent, COM902, has been administered to a patient for the first time as part of a phase 1 clinical trial evaluating COM902 in combination with the anti-PVRIG agent, COM701 in patients with advanced malignancies who have no alternative treatment options.

TiTAN-1 Trial of GEN-011 Initiates Treatment in Patients With Solid Tumors

July 13th 2021

The first patient with a solid tumor has been dosed in the TiTAN-1 clinical trial, which is aiming to determine the safety, tolerability, and efficacy of GEN-011, a next-generation neoantigen adoptive cell therapy.

BTX-A51 Treatment Initiated in Advanced Solid Tumor Malignancies

June 10th 2021

The first patient with an advanced solid tumor has been dosed in a phase 1 clinical trial of the multi-kinase inhibitor BTX-A51.

Novel CDK4/6 ARK5 Inhibitor Explored as a Treatment for Advanced Cancers

May 26th 2021

The investigational CDK4/6 ARK5 inhibitor, ON 123300, has been dosed in the first time in a patient whose is enrolled in a phase 1 trial of ON 123300 for the treatment of advanced cancers.

Safety/Feasibility of CAR T-Cell Therapy Being Investigated in Brain Tumors

May 18th 2021

The first patient has been dosed in a study designed to evaluate the safety and feasibility of IL13Rα2 chimeric antigen receptor T cell therapy for the treatment of leptomeningeal brain tumors, such as glioblastoma, ependymoma, and medulloblastoma.

Phase 3 Study of Imtelstat Versus BAT Explores Survival Improvement in Myelofibrosis

April 15th 2021

A phase 3 study with the goal of demonstrating overall survival benefit with imetelstat versus best available therapy in patients with refractory myelofibrosis has dosed the first patient with the experimental agent.

Study of CRX100 Makes Progress in Patients With Refractory Solid Tumors

March 5th 2021

The novel combined immunotherapy CRX100 has been dosed in the first patient with refractory solid tumors in a phase 1, open-label, dose-escalation study.

Novel T-Cell Based Immunotherapy Dosed Phase 2 Study of Patients With AML

March 3rd 2021

The first patient with acute myeloid leukemia in a phase 2 trial of the MultiTAA-specific T cell, MT-401 followed stem-cell transplant has been dosed with the agent, according to a press release by Marker Therapeutics, Inc.

MYC-Targeted Agent Dosed in First Patient in Early-Phase Solid Tumor Study

February 26th 2021

The first patient has been dosed in the phase 1/2 clinical trial of an oral CDK9 inhibitor targeting MYC-amplified solid tumors known as KB-0742.

NBTXR3 Injected in First Patient With Esophageal Cancer in Phase 1 Study

February 2nd 2021

In the phase 1 clinical trial of NBTXR3 with chemotherapy and radiation therapy as treatment of patients with esophageal cancer, the first patient has been dosed with the investigational tumor-agnostic radioenhancer.

Enzastaurin Dosed in First Phase 3 Study of Newly Diagnosed Glioblastoma Multiforme

January 11th 2021

The first patient with newly diagnosed glioblastoma multiforme has been dosed with the first-in-class small molecule enzastaurin in combination with temozolomide and radiotherapy in the phase 3 ENGAGE clinical trial with an aim of determining the overall survival outcome of the drug in this patient population.

Phase 3 Study Initiated to Explore Adjuvant Trastuzumab Deruxtecan in HER2+ Breast Cancer

November 10th 2020

A phase 3 study was initiated for a head-to-head comparison of trastuzumab deruxtecan versus T-DM1 as adjuvant treatment of a subset of patients with HER2-positive early breast cancer.

Neuro-Oncologists Await Late-Phase Clinical Trial Exploration of Enzastaurin in Glioblastoma

September 17th 2020

Enzastaurin is on track to serve an unmet medical need in the treatment landscape of glioblastoma. Neuro-oncologists are waiting on the launch of an important clinical trial to further demonstrate the efficacy of the drug.

Pivotal Phase 3 Trial Initiated to Study Promising Cabozantinib/Atezolizumab Combo in Advanced RCC

July 22nd 2020

A pivotal phase 3 trial has been initiated to explore the combination of cabozantinib and atezolizumab for the treatment of patients with inoperable, locally advanced or metastatic renal cell carcinoma who progressed during or after treatment with an immune checkpoint inhibitor immediately following initial therapy.

Phase III Study of Momelotinib Launched to Evaluate Efficacy in Patients With Myelofibrosis

December 9th 2019

The new phase III MOMENTUM clinical trial, which is evaluating the efficacy of momelotinib, a JAK1, JAK2 and ACVR1 inhibitor, versus active comparator danazol in patients with symptomatic and anemic myelofibrosis, was recently launched globally, according to a press release from Sierra Oncology.