Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing VS-7375 for Pancreatic Ductal Adenocarcinoma

This study will assess the safety and how well it works of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

Official registry: https://clinicaltrials.gov/study/NCT07020221 · Verastem, Inc. · enrollment listed as 616

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are VS-7375, Cetuximab, or Carboplatin + Pemetrexed + Pembrolizumab. The registry lists allocation as randomized. This study will assess the safety and how well it works of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.

They plan to enroll about 616 people at 22 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: VS-7375, Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab, Gemcitabine + Nab-paclitaxel, Pembrolizumab, Defactinib, Midazolam, Repaglinide

Primary outcome (registry wording): Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Individuals ≥18 years of age
  • 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

Public study contact (from the registry)

Verastem Call Center

1 781 292 4204

clinicaltrials@verastem.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

22 listed

+ 9 sites outside the US on the same record

Related recruiting trials in this snapshot

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Evaluation for NCI Surgery Branch Clinical Research Protocols

Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.

NCT00001823 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

FAQ about this NCT record

Is NCT07020221 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07020221?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07020221?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary