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RECRUITING
NCT06797336
PHASE1

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

Sponsor: PAQ Therapeutics, Inc.

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.

Official title: A Phase 1, Open-Label Dose Escalation and Expansion Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-12-19

Completion Date

2027-06-16

Last Updated

2026-08-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

PT0253

PT0253 injection.

DRUG

Chemotherapy Combination 1

Intravenous infusion.

DRUG

Chemotherapy Combination 2

Intravenous infusion.

DRUG

Chemotherapy Combination 3

Intravenous infusion.

DRUG

Cetuximab

Intravenous infusion.

Locations (15)

START Los Angeles

Los Angeles, California, United States

Dana Farber/Massachusetts General Hospital, Inc

Boston, Massachusetts, United States

START Midwest

Grand Rapids, Michigan, United States

SCRI Lake Mary

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

New Experimental Therapeutics of San Antonio LLC

San Antonio, Texas, United States

START - South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

NEXT Virginia

Fairfax, Virginia, United States

CHA University Bundang Medical Center

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea