Clinical Trials

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

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.

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

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.

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.

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

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.

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

The FDA has granted orphan drug designation to toripalimab for the treatment of patients with small cell lung cancer.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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

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.

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 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.

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

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

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.