Clinical Trials

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.

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.