A Phase 1, Open-label Dose Escalation and Expansion Study OF PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Men or women \>=18 years of age
• Histologically or cytologically confirmed advanced or metastatic solid malignancy.
• 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 provide clinical benefit.
• Measurable disease (RECIST 1.1 Criteria).
• ECOG Performance Status 0 or 1.
• Willingness to avoid pregnancy or fathering children screening through 90 days after the last dose of study treatment.
Locations
United States
Massachusetts
Dana-Farber/Massachusetts General Hospital, Inc
NOT_YET_RECRUITING
Boston
Texas
New Experimental Therapeutics of San Antonio LLC
RECRUITING
San Antonio
START - South Texas Accelerated Research Therapeutics, LLC
NOT_YET_RECRUITING
San Antonio
Utah
START Mountain Region
NOT_YET_RECRUITING
West Valley City
Virginia
NEXT Virginia
RECRUITING
Fairfax
Contact Information
Primary
PAQ Therapeutics
ClinicalTrials@paqtx.com
781-819-2949
Time Frame
Start Date:2025-11-21
Estimated Completion Date:2028-10-18
Participants
Target number of participants:195
Treatments
Experimental: Part 1a: Dose Escalation
Participants with solid tumors with any KRAS mutation or amplified WT KRAS will receive PT0511 infusion, intravenously (IV), until disease progression or intolerance.
Experimental: Part 1b: Dose Expansion: Tumor type 1
Participants with tumor type 1 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 2
Participants with tumor type 2 will receive PT0511 infusion in combination with cetuximab infusion, until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 3
Participants with tumor type 3 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 4
Participants with tumor type 4 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 5
Participants with tumor type 5 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 6
Participants with tumor type 6 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 7
Participants with tumor type 7 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.
Experimental: Part 1b: Dose Expansion: Tumor type 8
Participants with tumor type 8 will receive PT0511 infusion until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0511 established in Part 1a.