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A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 240 → 300 participants Eligibility criteria expanded, about 126 words · Secondary endpoints: details revised at 2 of 11 entries · Site details revised at 1 of 15 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 126 words
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised at 1 of 15 sites
  2. Enrollment increased: 115 → 240 participants Trial sites expanded: 7 → 15 locations · Trial arms changed: 4 → 5 · Interventions: PT0253 (Drug) to Cetuximab (Drug), Chemotherapy Combination 1 (Drug), Chemotherapy Combination 2 (Drug), Chemotherapy Combination 3 (Drug), PT0253 (Drug) · 1 morev4 Show 4 more changesShow less
    • Trial sites expanded: 7 → 15 locations
    • Trial arms changed: 4 → 5
    • Interventions: PT0253 (Drug) to Cetuximab (Drug), Chemotherapy Combination 1 (Drug), Chemotherapy Combination 2 (Drug), Chemotherapy Combination 3 (Drug), PT0253 (Drug)
    • Eligibility criteria expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 5 to 7v3
  4. Study sites: 3 to 5 Start date changed from estimate of Jan 2025 to Dec 19, 2024v2 Show 1 more changeShow less
    • Start date changed from estimate of Jan 2025 to Dec 19, 2024
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.
Trial Details
NCT Number NCT06797336
Lead Sponsor PAQ Therapeutics, Inc.
Conditions Solid Tumor
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov