A Phase 1, Open-label Dose Escalation and Expansion Study OF PT0511 in Participants With KRAS Mutated OR Amplified 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 PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Men or women \>=18 years of age 2. Histologically or cytologically confirmed advanced or metastatic solid malignancy. 3. Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test. • Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to pr…
Interventions
- DrugPT0511
Intravenous infusion.
- DrugCetuximab
Intravenous infusion.
Locations (5)
- Dana-Farber/Massachusetts General Hospital, IncBoston, Massachusetts
- New Experimental Therapeutics of San Antonio LLCSan Antonio, Texas
- START - South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas
- START Mountain RegionWest Valley City, Utah
- NEXT VirginiaFairfax, Virginia