TARGET-D 201
TARGET-D 201 Evaluating VS-7375 in KRAS G12D-Mutated Pancreatic Cancer
VS-7375 is an investigational oral KRAS G12D (ON/OFF) inhibitor that is being studied in a Phase 2, open-label study known as TARGET-D 201. VS-7375 is being evaluated both as monotherapy and with cetuximab in patients with previously treated metastatic KRAS G12D-mutated pancreatic cancer. A cohort of the study will also evaluate VS-7375 in combination with cetuximab in the first-line setting in patients with metastatic pancreatic cancer. VS-7375 is given once daily as an oral therapy and cetuximab is given via intravenous infusion. The study is registered at ClinicalTrials.gov (NCT07644559).
Summary
Clinical Trial Overview
This study is evaluating the safety and efficacy of VS-7375 in people with pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) that has spread to other parts of the body and has a KRAS G12D gene mutation. VS-7375 targets this mutation to help block signals that drive tumor growth. All participants who take VS-7375 are randomly assigned to treatment as:
- Monotherapy, on its own, or
- Combination therapy, taken with cetuximab or panitumumab, medicines already approved by the FDA to treat certain cancers.
Participants who have received prior treatment will be assigned to either Cohort A1/B1 or A2/B2 as below. Participants who have received no prior treatment* will be assigned to Cohort C.
- Cohort A1 and B1: VS-7375 as a monotherapy
- Cohort A2 and B2: VS-7375 as a combination therapy
- Cohort C: VS-7375 as a combination therapy.
*Part C Only: Participants can receive one cycle of chemotherapy (no more than 28 days).
Eligibility and Inclusion Criteria
Each clinical trial has specific eligibility criteria, which may include factors such as age, sex, disease type or stage, prior treatments, and other medical conditions. Key criteria include:
Inclusion Criteria
- Are 18 years of age or older
- Have been diagnosed with metastatic pancreatic ductal adenocarcinoma with a KRAS G12D mutation
- Have at least one tumor that can be measured on a scan
- Cohort A1/B1/A2/B2: Participants must have had at least one line of treatment
Exclusion Criteria
- Recent major surgery
- Received certain types of chemotherapy, anti-cancer therapy or radiotherapy
- Treatment with prior investigational therapy
This is a summary of the main eligibility criteria. Eligibility is determined by the study doctor based on the trial’s requirements and an individual’s medical history and health status.
Clinical Trial Sites
TARGET-D 201 is actively recruiting, and the most up-to-date trial sites can be found at the listing on clinicaltrials.gov. For more information, visit the listing or contact us at 781-292-4204 or VS-7375-201TrialSupport@verastem.com.
Participants are required to visit the study site at least once during the 28-day screening period. Following screening, site visits are dependent on assigned treatment arm and all cycles are 28 days:
- Monotherapy: Two site visits during first cycle; one site visit every remaining cycle
- Combination therapy: At least two site visits (but up to four) every cycle.
Financial assistance and/or travel reimbursement are available for participants enrolled in the study.