A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
← catalyst calendarNCT07020221 · readout ≤ 865 d
Sponsored by Verastem, Inc. (industry) · VSTM — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
295estimated
Sites
14
Countries
Australia, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-24 | actual | When the study began enrolling |
| Primary completion | Dec 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pancreatic Ductal Adenocarcinoma
- Non Small Cell Lung Cancer
- Colorectal Cancer
- Solid Tumor, Adult
- G12D Mutated KRAS
Interventions
- Drug: VS-7375
- Drug: Cetuximab — also filed as Erbitux
- Drug: Carboplatin + Pemetrexed + Pembrolizumab
- Drug: Gemcitabine
- Drug: Gemcitabine + Nab-paclitaxel
Primary outcomes
what the primary-completion date above is the date OFPart A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375
measured Up to 2.5 years
Part A: To identify the MTD or MFD
measured Cycle 1 (each cycle is 21 days)
Part B: To evaluate the preliminary anticancer activity of the optimal VS-7375 regimen
measured Up to 2.5 years
Part C: To characterize the safety, tolerability, and AE profile of VS-7375 in combination regimens.
measured From enrollment to the end of treatment; an average of 9 months
Part C: To identify a recommended dose for subsequent studies of combination dosed VS-7375.
measured Cycle 1 (each cycle is 21 or 28 days)
Part D: To determine the preliminary anticancer activity of the optimal regimen of VS-7375 as identified in Part C
measured Up to 2.5 years
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