TARGET-D 203
TARGET-D 203 Evaluating VS-7375 in KRAS G12D-Mutated Colorectal 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 203. VS-7375 is being evaluated both as monotherapy and in combination with an anti-EGFR antibody and chemotherapy in patients with previously treated metastatic KRAS G12D-mutated colorectal cancer. TARGET-D 203 will also evaluate VS-7375 in combination with anti-EGFR and chemotherapy in first line setting. VS-7375 is given once daily as an oral therapy, anti-EGFR and chemotherapy are given via intravenous infusion. The study is registered at ClinicalTrials.gov (NCT07659795).
Summary
Clinical Trial Overview
This study is evaluating the safety and efficacy of VS-7375 in people with metastatic colorectal cancer who have a KRAS G12D gene mutation. VS-7375 targets this mutation to help block signals that drive tumor growth. Participants who have received prior treatment will be assigned to either cohort A1, A2, or B as below. Participants who have received no prior treatment* will be assigned to cohort C.
- Cohorts A1 and B: VS-7375 combination therapy with cetuximab or panitumumab
- Cohorts A2 and B: VS-7375 monotherapy
- Cohort C: Combination therapy with cetuximab and chemotherapy
Participants will be made aware of the treatment group to which they were assigned.
*Individuals who received no more than 1 cycle (no more than 28 days) also included in Cohort C.
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 colorectal cancer with a KRAS G12D mutation
- Have at least one tumor that can be measured on a scan
- Cohort A1/A2/B: participants must have had at least 1 line of prior 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 203 is actively recruiting and the most up-to-date trial sites can be found on the listing on clinicaltrials.gov. For more information, visit the listing or contact us at 781-292-4204 or VS-7375-203TrialSupport@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 treatment arm, and all cycles are 28 days:
- Cohort A1 (VS-7375 + Cetuximab or Panitumumab): At least two site visits, but up to four every cycle
- Cohort A2 (VS-7375 Monotherapy): Three site visits during first cycle,one site visit every cycle following
- Cohort C (VS-7375 + Cetuximab + mFOLFOX6): Four site visits during first two cycles; two site visits every cycle following
Cohort B will follow the schedule of whichever regimen is selected as preferred after Part A’s interim analysis — either the Cohort A1 schedule (combination therapy) or Cohort A2 schedule (monotherapy). Financial assistance and/or travel reimbursement are available for participants enrolled in the study.