A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated 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 PT0253 in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutated advanced solid tumors as monotherapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically or cytologically confirmed advanced or metastatic solid malignancy
• 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.
• Measurable disease (RECIST 1.1 Criteria).
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
• Willingness to avoid pregnancy or fathering children from screening through 90 days after the last dose of study treatment.
Locations
United States
Massachusetts
Dana Farber/Massachusetts General Hospital, Inc
RECRUITING
Boston
Texas
New Experimental Therapeutics of San Antonio LLC
RECRUITING
San Antonio
START - South Texas Accelerated Research Therapeutics, LLC
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
NEXT Virginia
RECRUITING
Fairfax
Contact Information
Primary
PAQ Therapeutics
ClinicalTrials@paqtx.com
781-819-2949
Time Frame
Start Date:2024-12-19
Estimated Completion Date:2027-06-16
Participants
Target number of participants:115
Treatments
Experimental: Part 1a, Dose Escalation
Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance.
Experimental: Part 1b, Dose Expansion: Tumor type 1
Participants with a previously treated tumor type will receive PT0253 injection 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 PT0253 established in Part 1a.
Experimental: Part 1b, Dose Expansion: Tumor type 2
Participants with a previously treated tumor type will receive PT0253 injection 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 PT0253 established in Part 1a.
Experimental: Part 1b, Dose Expansion: Tumor type 3
Participants with a previously treated tumor type will receive PT0253 injection 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 PT0253 established in Part 1a.