Clinical Trials

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.

The phase 1 INSIGHT-005 trial will further evaluate the combination of eftilagimod alpha and avelumab in patients with metastatic urothelial cancer.

A phase 1 trial evaluating 5-aminolevulinic acid and CV01 delivery of ultrasound has begun treating the first 3 of approximately 33 patients with recurrent high-grade glioma.

Part 2 of the NOVA-II phase 2 trial evaluating OQL011 has enrolled the first patient with cancer with VEGFR inhibitor-associated hand-foot skin reaction.

The newly launched phase 2 LenCabo study of lenvatinib with everolimus vs cabozantinib for the second- or third-line treatment of metastatic renal cell carcinoma.

A phase 1/2 clinical trial evaluating treatment with MRT-2359 in MYC-driven solid tumors has dosed its first patient and looks to improve early signals of clinical activity.

Following positive results and FDA action on pidnarulex in BRAC 1/2-positive ovarian cancer, a phase 1 study is exploring the agent in metastatic castration-resistant prostate cancer, in combination with talazoparib.

A phase 1/2 study of ZN-c3, encorafenib, and cetuximab in patients with BRAF V600E-mutated colorectal cancer will begin, led by Zentalis Pharmaceuticals and Pfizer.