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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 13 to 14v10
  2. Study sites: 12 to 13v9
  3. Study sites: 10 to 12v8
  4. Site contacts updated at 1 of 10 sitesv7
  5. Site contacts updated at 1 of 10 sites Study title revisedv6 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoints revised (6) Enrollment target: 330 to 295 · Study sites: 5 to 10 · Primary and study completion dates: Sep 2028 to Dec 2028 · 2 morev5 Show 5 more changesShow less
    • Enrollment target: 330 to 295
    • Study sites: 5 to 10
    • Primary and study completion dates: Sep 2028 to Dec 2028
    • Eligibility criteria shortened, about 27 words
    • Secondary endpoints: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 130 to 330 Interventions: Cetuximab (Drug), VS-7375 (Drug) to Carboplatin + Pemetrexed + Pembrolizumab (Drug), Cetuximab (Drug), Gemcitabine (Drug), Gemcitabine + Nab-paclitaxel (Drug), VS-7375 (Drug) · Site contacts updated at 1 of 5 sites · Study arms: 4 to 10v4 Show 3 more changesShow less
    • Interventions: Cetuximab (Drug), VS-7375 (Drug) to Carboplatin + Pemetrexed + Pembrolizumab (Drug), Cetuximab (Drug), Gemcitabine (Drug), Gemcitabine + Nab-paclitaxel (Drug), VS-7375 (Drug)
    • Site contacts updated at 1 of 5 sites
    • Study arms: 4 to 10
  3. Study sites: 3 to 5 Start date changed from estimate of Jun 2025 to Jun 24, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Jun 2025 to Jun 24, 2025
  4. Trial status: Not Yet Recruiting to Recruiting Site details revised at 3 of 3 sitesv2 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Verastem, Inc.
11 trials monitored
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Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT07020221
Lead Sponsor Verastem, Inc.
Conditions Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult, G12D Mutated KRAS
Enrollment 295 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov