Clinical Trials

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.

With all patients with solid tumors enrolled in the phase 1 study of QBS72S, 2 more studies evaluating the agent in brain malignancies will commence.

A suspected unexpected serious adverse reaction to seclidemstat led the developer to pause a phase 1/2 evaluating the agent in patients with Ewing and FET-rearranged sarcoma.

The phase 2 DeFianCe study will evaluate the safety and efficacy of DKN-01 combined with bevacizumab and chemotherapy in patients with colorectal cancer vs becazixumab and chemotherapy alone.

As part of the phase 2 INSIGhT trial, VBI Vaccines, Inc, and Agenus will examine the combination of VBI-1901 and balstilimab in patients with glioblastoma.

The first of 160 patients with gastric or gastroesophageal junction cancer has been recruited for the phase 2 DisTinGuish study. Thirty-two study locations are actively recruiting more patients.

The PRESERVE 2 trial evaluating trilaciclib in patients with metastatic breast cancer has finished enrolling patients. Results from the interim analysis of the trial is expected in the second half of 2023.

Considering the potential to fill a treatment gap in the KRAS G12C-mutant non–small cell lung cancer population, the FDA has granted a fast track designation to the combination of BBP-398 and sotorasib.