Trials / Recruiting
RecruitingNCT07020221
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 295 (estimated)
- Sponsor
- Verastem, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Non Small Cell Lung Cancer
- Colorectal Cancer
- Solid Tumor, Adult
- G12D Mutated KRAS
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VS-7375 | VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor. |
| DRUG | Cetuximab | Cetuximab is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR). |
| DRUG | Carboplatin + Pemetrexed + Pembrolizumab | A combination therapy regimen used as a first-line treatment for advanced non-squamous non-small cell lung cancer. |
| DRUG | Gemcitabine | A chemotherapy used for the treatment of several types of cancer including advanced or metastatic pancreatic ductal adenocarcinoma. |
| DRUG | Gemcitabine + Nab-paclitaxel | A chemotherapy regimen used for the treatment of advanced or metastatic pancreatic ductal adenocarcinoma. |
Timeline
- Start date
- 2025-06-24
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2025-06-13
- Last updated
- 2026-04-03
Locations
13 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07020221. Inclusion in this directory is not an endorsement.