UPCC 24925 A Phase 1/2a, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients with Advanced KRAS G12D-Mutant Solid Tumors

Study of Investigational Medication on Advanced Solid Tumors with KRAS G12D Mutation

Enrolling By Invitation
18 years or above
All
Phase 1/2
295 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult, G12D Mutated KRAS
  • Age: 18 years or above
  • Gender: All

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.
  • 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.

This study investigates the effects of an investigational medication on patients with advanced solid tumors that have a KRAS G12D mutation. The purpose is to understand the safety and effectiveness of the investigational medication when used alone and in combination with other treatments.

Participants in the study will receive the investigational medication either as a single treatment or alongside other therapies. The study will monitor the participants' health and how their tumors respond to the treatment. The study will also require participants to undergo regular health checks and assessments to evaluate the safety and effectiveness of the treatment.

  • Who can participate: Adults aged 18 and over with advanced solid tumors that have a KRAS G12D mutation may participate. Participants must have measurable disease and a good performance status. They must also have adequate organ and cardiac function and agree to use effective contraception.
  • Study details: Participants will receive the investigational medication either alone or in combination with other treatments. They will need to attend regular health assessments to monitor the effects of the treatment and ensure safety.
Updated on 22 Apr 2026. Study ID: 25-1958
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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