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

NCT07020221 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2026-04-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Verastem, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020221 on ClinicalTrials.gov