Clinical Trials

The safety and efficacy of the combination of lifileucel and pembrolizumab is being assessed in the phase 3 TILVANCE-301 among patients with untreated, unresectable, or metastatic melanoma.

Although dosing will continue in iMMagine-1 for patients who responded well to CART-ddBCMA, recruitment has been halted due to to a safety concern.

The FDA is no longer concerned about the safety of MT-0169, and the developer of the agent plans to focus its effort on the extramedullary myeloma population.

ACTION-1 is investigating RYZ101 versus standard-of-care therapy in patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors after 177Lu-SSA therapy.

A phase 1 study is exploring gamma delta T-cell therapy for the first time in patients with relapsed or refractory B-cell malignancies.

The claudin 18.2 antibody-drug conjugate ATG-022 is being investigated in a phase 1 study as a potential treatment for advanced or metastatic solid tumors.

Development of PYX-201 in advanced solid tumors is underway, and the drug has grabbed the FDA's attend with a phase 1 study in pancreatic cancer.

This trial of HST-1011 will evaluate the safety, tolerability, pharmacokinetics, harmacodynamics, and preliminary clinical activity of the agent when administered as a monotherapy or in combination with cemiplimab.

According to Alice P. Chen, MD, the phase 2 study of atezolizumab alone or atezolizumab plus bevacizumab has a unique design.

A patient treated with the second highest dose level of FHD-609 had a grade 4 adverse event. Enrollment in the study of the agent in patients with synovial sarcoma or SMARCB-1 deleted tumors has been halted.

The FDA continues to push forward PSMA-targeted therapies to address unmet needs for patients with metastatic castration-resistant prostate cancer.

A phase 1 trial of EPI-7386 will evaluate the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of the agent in combination with apalutamide or abiraterone acetate plus prednisone.

DKN-01, an anti-DKK1 antibody, is being evaluated with bevacizumab and chemotherapy for patients with advanced colorectal cancer in the phase 2 DeFianCe trial.

The phase 3 MAJIC study is underway to compare 2 frontline regimens for patients with chronic lymphocytic leukemia.

Results from the EARLY-MYO-BC trial assessing the pyrotinib’s cardiac impacts may help researchers select an appropriate anti-HER2 treatment when managing patients with HER2-positive breast cancer.

Roby Thomas, MD, provides ideas for oncologists to consider while multiple chemotherapy drug are on shortage in the United States.

A phase 2, open-label clinical trial is evaluating treatment with QBS72S in patients with histologically-confirmed breast cancer that has developed brain metastases after a prior cytotoxic chemotherapy regimen.

A first-in-human study is assessing the safety, efficacy, and pharmacokinetics of DK210 as a monotherapy and in combination with immunotherapy, radiotherapy, or chemotherapy for patients with EGFR-expressing solid tumors.

A Tennessee Oncology location in Nashville was the first to dose the novel c-MET antibody-drug conjugate, MYTX-011, as part of the phase 1 KisMET-01 clinical trial.

The next-generation anthracycline Annamycin has been administered to the first patient with relapsed/refractory acute myeloid leukemia in combination with cytarabine in a phase 1/2 study.

The inaugural participant with AML showing a mutation of FLT3 in a relapsed/refractory form has been recruited into the Phase 1 FRIDA trial.

PT886, a novel bispecific antibody which targets claudin 18.2 and CD47, is currently being evaluated in a phase 1 study for patients with gastric, gastroesophageal junction and pancreatic adenocarcinomas.

The FDA released a draft guidance for drug sponsors of clinical trials in oncology, outlining its move toward requiring randomized controlled trials to grant accelerated approvals for most oncology therapeutics.

Ripretinib will be evaluated in a phase 3 trial for patients with gastrointestinal stromal tumor after being added to the NCCN guidelines and receiving 2 breakthrough therapy designations from the FDA.

The combination of CDK9 plus BTK inhibition has already demonstrated synergistic clinical efficacy vs BTK inhibition alone. Now, a clinical trial collaboration will evaluate PRT2527 and zanubrutinib for patients with hematologic malignancies.

A phase 1b/2a trial is investigating the combination of bemcentinib with pembrolizumab and doublet chemotherapy in patients with first-line non–small cell lung cancer that harbors STK11 mutations.

A phase 1 study is investigating anti-TIGIT therapy combined with immune checkpoint inhibition for the patients with metastatic microsatellite stable colorectal cancer.

JWATM214, an autologous T-cell immunotherapy candidate drug targeting GPC-3 for patients with advanced hepatocellular carcinoma, is now being investigated in a phase 1 trial.

A new study investigation ART0380 and gemcitabine for the treatment of patients with platinum-resistant ovarian cancer has begun.

In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee supported the proposed clinical trial for dostarlimab as treatment of locally advanced, treatment-naïve mismatch-repair deficient or microsatellite-instability-high rectal cancer.