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

V

Verastem

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

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

Treatments

Drug: Cetuximab
Drug: VS-7375

Study type

Interventional

Funder types

Industry

Identifiers

NCT07020221
VS-7375-101

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • 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.
  • Must have received ≥1 prior line of standard systemic therapy for advanced or metastatic disease or experienced cancer progression within 6 months of neoadjuvant or adjuvant therapy.
  • 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

Key Exclusion Criteria:

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

130 participants in 4 patient groups

VS-7375 Dose Escalation
Experimental group
Description:
To determine the recommended phase 2 dose (RP2D) for VS-7375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
Treatment:
Drug: VS-7375
Cetuximab + VS-7375 Dose Escalation
Experimental group
Description:
To determine the recommended phase 2 dose (RP2D) for cetuximab + VS-7375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
Treatment:
Drug: VS-7375
Drug: Cetuximab
VS-7375 Recommended Phase 2 Dose Expansion
Experimental group
Description:
To determine the efficacy of VS-7375 at the recommended phase 2 dose (RP2D) in patients with advanced PDAC and NSCLC harboring a KRAS G12D mutation.
Treatment:
Drug: VS-7375
Cetuximab + VS-7375 Recommended Phase 2 Dose Expansion
Experimental group
Description:
To determine the efficacy of cetuximab +VS-7375 at the recommended phase 2 dose (RP2D) in patients with advanced CRC harboring a KRAS G12D mutation.
Treatment:
Drug: VS-7375
Drug: Cetuximab

Trial contacts and locations

3

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Central trial contact

Verastem Call Center

Data sourced from clinicaltrials.gov

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