Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 3 changes
notable Enrollment increased: 115 -> 240 participants 2026-08-13
minor Trial arms changed: 4 -> 5 2026-08-13
notable Trial sites expanded: 7 -> 15 locations 2026-08-13
Trial Details
NCT Number NCT06797336
Lead Sponsor PAQ Therapeutics, Inc.
Conditions Solid Tumor
Enrollment 240 participants
Start Date 2024-12-19
Primary Completion 2026-12-15 (estimated)
Study Completion 2027-06-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-12