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Study of VS-7375 for KRAS G12D-Mutated Solid Tumors

This study is testing a new drug called VS-7375, alone and in combination with other treatments like Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab, Gemcitabine, or Gemcitabine + Nab-paclitaxel. VS-7375 is a targeted therapy that works by blocking a specific change (mutation) in the KRAS gene called G12D, which is found in some cancers. This study is for adults with advanced solid tumors, including pancreatic, lung, and colorectal cancers, that have this specific KRAS G12D mutation. The main goals are to understand the safety and side effects of VS-7375 and to see how well it works against the cancer. The study is currently recruiting about 295 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll about 295 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2.5 years to assess the drug's safety and effectiveness.

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NCT07020221

A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Verastem, Inc.
~295 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:VS-7375CetuximabCarboplatin + Pemetrexed + PembrolizumabGemcitabineGemcitabine + Nab-paclitaxel

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375
Measured over Up to 2.5 years
+5 more outcomes measured

Conditions

Pancreatic Ductal Adenocarcinoma
Non Small Cell Lung Cancer
Colorectal Cancer
Solid Tumor, Adult
G12D Mutated KRAS

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRas

Where it's being run

14 sites across 13 states
Virginia2
California1
Maryland1
Massachusetts1
Michigan1
Missouri1
New York1
Pennsylvania1

Who to contact

Verastem Call Center
[email protected]
1 781 292 4204
Email the study team

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Eligibility criteria

Inclusion

Individuals ≥18 years of age.
Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ function
Adequate cardiac function
Recovered from all AEs due to previous therapies to Grade ≤1 or baseline.
Agreement to use highly effective contraception

Exclusion

Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1,
Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1
Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.
History of treatment with direct and specific KRAS G12D inhibitors.
Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.
Inability to swallow oral medications.
Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease
Individuals who are pregnant or breastfeeding.

What this trial measures

  • Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375Up to 2.5 years

    To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375 administered on a daily oral schedule in participants with advanced solid tumors harboring a KRAS G12D mutation. Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, DLTs, and dose interruptions/reductions.

  • Part A: To identify the MTD or MFDCycle 1 (each cycle is 21 days)

    To identify the MTD or MFD using a BOIN design and recommend a dose for subsequent studies of VS-7375 on a daily oral schedule in participants with any KRAS G12D-mutated solid tumor. Proportion/number of participants with DLTs during the DLT assessment period (through C1D21).

  • Part B: To evaluate the preliminary anticancer activity of the optimal VS-7375 regimenUp to 2.5 years

    To evaluate the preliminary anticancer activity of the optimal VS-7375 regimen identified from Part A in participants with advanced KRAS G12D-mutated PDAC (cohort B1), NSCLC (cohort B2), and other solid tumors (cohort B3). Confirmed ORR, PFS rate, unconfirmed PR and CR rates, DCR, DOR, and PFS per RECIST v1.1. Overall Survival

  • Part C: To characterize the safety, tolerability, and AE profile of VS-7375 in combination regimens.From enrollment to the end of treatment; an average of 9 months

    To characterize the safety, tolerability, and AE profile of VS-7375 in the following combination regimens in participants with any solid tumor harboring a KRAS G12D mutation. * 2L+ therapy in combination with cetuximab in participants with any advanced or metastatic solid tumor harboring a KRAS G12D mutation * 1L therapy in combination with carboplatin, pembrolizumab, and pemetrexed in participants with previously untreated metastatic NSCLC * 2L+ therapy in combination with gemcitabine and nab-paclitaxel in participants with metastatic PDAC * 1L therapy in combination with gemcitabine in participants aged 75 years or older with previously untreated metastatic PDAC. Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, DLTs, and dose interruptions/reductions.

  • Part C: To identify a recommended dose for subsequent studies of combination dosed VS-7375.Cycle 1 (each cycle is 21 or 28 days)

    To identify a recommended dose for subsequent studies of combination dosed VS-7375. Proportion/number of participants with DLTs during the DLT assessment period (through end of Cycle 1).

  • Part D: To determine the preliminary anticancer activity of the optimal regimen of VS-7375 as identified in Part CUp to 2.5 years

    To determine the preliminary anticancer activity of the optimal regimen of VS-7375 as identified in Part C as: * 2L+ therapy in combination with cetuximab in participants with metastatic colorectal adenocarcinoma * 1L therapy in combination with carboplatin, pembrolizumab, and pemetrexed in participants with previously untreated metastatic NSCLC * 2L+ therapy in combination with gemcitabine and nab-paclitaxel in participants with metastatic PDAC * 1L therapy in combination with gemcitabine in participants aged 75 years or older with previously untreated metastatic PDAC. Confirmed ORR, PFS rate, unconfirmed PR and CR rates, DCR, DOR, and PFS per RECIST v1.1. Overall survival