RightFit
RecruitingPhase 2

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)

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 for colorectal cancer that has spread and has a KRAS G12D gene change. It tests VS-7375 alone, with cetuximab or panitumumab, or with cetuximab plus a chemotherapy mix called mFOLFOX.

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab or panitumumab and cetuximab plus mFOLFOX in patients with metastatic KRAS G12D - mutated Colorectal Cancer

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

Eligibility

Who can join

  • Have colorectal cancer that has spread to other parts of the body, confirmed by a tissue test.
  • Have cancer that can be measured using standard study rules.
  • Have a KRAS G12D gene change confirmed by local testing, and provide tissue for another test to confirm it.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • If previously treated: have received at least one standard chemotherapy for colorectal adenocarcinoma that has spread.
  • If previously treated: have records showing the cancer grew or spread during or after the most recent treatment.
  • If previously treated: during at least one past treatment that worked throughout the body, the cancer stayed stable, shrank, or disappeared.
  • If starting first-line treatment: have had no treatment, or no more than one cycle of standard treatment that works throughout the body, for cancer that has spread.

Who can't join

  • Have another known common RAS gene change.
  • Had cancer treatment within 4 weeks before the first study dose, or within a shorter time set for that drug.
  • Had major surgery within 4 weeks or radiation treatment within 1 week before the first study dose.
  • Have taken a drug that directly blocks RAS, or have received more than one experimental treatment.
  • Have cancer that has spread to the brain or spinal cord and is untreated or causing symptoms.
  • Recently took certain medicines that strongly affect a liver enzyme called CYP3A4, or medicines processed by it whose safe dose range is small. The limit is 14 days before the first study dose, or a shorter time set for the drug.
  • Took a proton pump inhibitor (PPI) or H2 blocker, which reduce stomach acid, within 5 days, or cannot swallow medicine.
  • Other study rules may also affect who can join.

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

Official eligibility criteria

Inclusion Criteria: * Histopathology confirmed metastatic CRC * Measurable disease per RECIST 1.1 * Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing) * ECOG PS=0 or 1 2L+ patients: * Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma * Have documented disease progression during or following their most recent prior line of therapy * Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy. 1L patients: * Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease. Exclusion Criteria: * Have any other documented co-existing common RAS mutation(s) * Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter * Major surgery within 4 weeks of first treatment dose * Radiation therapy (RT) within 1 week of first treatment dose * Receipt of prior direct RAS inhibitor * Receipt of more than 1 investigational therapy * Untreated or symptomatic CNS metastasis * Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter * Receipt of PPI or H2 blocker within 5 days * Inability to swallow oral medication * Other protocol-defined inclusion/exclusion criteria may apply

Study sites (19)

CA

FL

IN

MI

MO

NC

NJ

NY

OH

TN

TX

UT

VA

WA

WI