Clinical Trials

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The FDA released a draft guidance for drug sponsors of clinical trials in oncology, outlining its move toward requiring randomized controlled trials to grant accelerated approvals for most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

The UPGRADE-A trial assessing the combination of upifitamab rilsodotin and carboplatin in patients with platinum-sensitive high-grade serous ovarian cancer has initiated the dose-expansion portion of the study.

The phase 1/2 LUMINOS-103 trial will evaluate the intravesical instillation of lerapolturev in a cohort of patients with non-muscle-invasive bladder cancer.

A first-in-human, multicenter, phase 1 clinical trial will begin to assess the safety, and biomarkers for response of DK210 in patients with advanced solid cancer who are overexpressing EGFR.

The START-001 trial will administer STAR0602 to patients with PD-1 refractory advanced solid tumors in order to evaluate the safety, tolerability, and preliminary clinical activity of the agent as a monotherapy.

The novel FLT3 inhibitor, tuspetinib, will be investigated further in patients with FLT3-positive acute myeloid leukemia.

An investigational immunotherapy triplet combination is showing promise for the treatment of advanced solid tumors. Recruitment for the phase 2 study continues.

Following positive data from the phase 1 ReSPECT-GBM trial, the first patient has been dosed with rhenium (186Re) obisbemeda in the phase 2 portion.

After the FDA cleared an investigational new drug application for mocravimod in April 2022, the first patients with acute myeloid leukemia undergoing allogeneic hematopoietic cell transplant have been enrolled in a phase 2b/3 study of the agent.

Months after the FDA granted accelerated approval to dostarlimab for this rectal cancer indication, phase 2 data have confirmed its efficacy and safety.

Following clearance by the FDA and AEMPS, the phase 2b VIRAGE trial of VCN-01 plus gemcitabine and nab-paclitaxel dosed its first patient with pancreatic ductal adenocarcinoma.

The phase 1 study of ADXS-504 for the treatment of early prostate cancer is ongoing and new patients with be enrolled to test a higher dose level.

JBI-802, which is being evaluated in a phase 1/2 trial, received an orphan drug designation from the FDA for the treatment of patients with small cell lung cancer and acute myeloid leukemia.

After preclinical and early clinical studies show promising data with CTX-009 therapy, a phase 2 study of the agent has dosed its first patient with metastatic colorectal cancer.

Patients with small cell lung cancer will receive diagnostic and post-progression tumor tissue profiling, plasma ctDNA biomarker profiling, standard of care therapy, and disease surveillance in the Sculptor study.

The CSP-targeting antibody, ZB131, is being investigated in a phase 1/2 study of patients with pancreatic cancer and other solid tumors.

VIKTORIA-1 is a phase 3 study evaluating treatment with gedatolisib plus fulvestrant with or without palbociclib in patients with HR-positive, HER-negative breast cancer.