A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors
PAQ Therapeutics, Inc.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced or metastatic solid malignancy 2. Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a validated institutional or commercial test. 3. Measurable disease (RECIST 1.1 Criteria). 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. 5. Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment. Exclusion Criteria: 1. Active brain metasta…
Interventions
- DrugPT0253
PT0253 injection.
Locations (7)
- Dana Farber/Massachusetts General Hospital, IncBoston, Massachusetts
- SCRI Lake MaryNashville, Tennessee
- SCRI Oncology PartnersNashville, Tennessee
- New Experimental Therapeutics of San Antonio LLCSan Antonio, Texas
- START - South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas
- START Mountain RegionWest Valley City, Utah