Phase 1/2Recruiting
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors
- Sponsor
- Verastem, Inc. (Industry)
- Enrolment
- 616 planned
- Conditions
- Pancreatic Ductal Adenocarcinoma; Non Small Cell Lung Cancer; Colorectal Cancer; Solid Tumor, Adult; G12D Mutated KRAS
- Interventions
- VS-7375; Cetuximab; Carboplatin + Pemetrexed + Pembrolizumab; Gemcitabine + Nab-paclitaxel; Pembrolizumab; Defactinib; Midazolam; Repaglinide
- Ages
- adults, older adults
- Registry
- NCT07020221
Full record on ClinicalTrials.gov
From the registry
This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
Primary outcomes
- Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375
- Part A: To identify the MTD or MFD
- Part B: To evaluate the preliminary anticancer activity of the optimal VS-7375 regimen
- Part C: To characterize the safety, tolerability, and AE profile of VS-7375 in combination regimens.
History
Primary completion expected
Last registry update
Started
Registered