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RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe VS-7375 is and how well it works, alone and with other treatments. It is for adults with advanced solid tumors that have a gene change called KRAS G12D.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You agree to sign and date a form giving your consent to join.
  • Tests show a solid tumor with the KRAS G12D gene change. The cancer has spread nearby and cannot be removed by surgery, or has spread to other parts of the body.
  • Your cancer can be measured using the study’s rules.
  • You can do all your usual activities, or have trouble only with hard physical activity.
  • Your organs, including your heart, work well enough for the study.
  • Side effects from past treatments are mild or have returned to your usual level.
  • You agree to use highly effective birth control.

Who can't join

  • You had major surgery within 4 weeks before starting study treatment, unless it was done to diagnose your condition.
  • You recently had chemotherapy, targeted cancer treatment, radiation, or immune-based treatment. The waiting period is generally 4 weeks, but may be shorter for some treatments. Radiation to ease symptoms is allowed.
  • You received an experimental drug before starting study treatment. The study team will check the timing rules.
  • You have ever received a drug that directly blocks RAS proteins.
  • You have cancer that has spread to the brain or spinal cord and causes symptoms, is untreated, or is getting worse.
  • You cannot swallow medicines.
  • You have, or have had, a serious, uncontrolled illness affecting your organs, blood, hormones, mental health, blood clotting, nerves, skin, or immune system, or a serious, uncontrolled allergic condition.
  • You are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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. * 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 RAS 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.

Study sites (13)

CA

MA

MD

MI

MO

NY

PA

TN

TX

UT

VA

WA