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RECRUITING
NCT07300150
PHASE1

A Study of PT0511 in Participants With KRAS Mutated or Amplified 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 PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).

Official title: A Phase 1, Open-label Dose Escalation and Expansion Study Of PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2025-11-21

Completion Date

2028-10-18

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

PT0511

Intravenous infusion.

DRUG

Cetuximab

Intravenous infusion.

Locations (9)

Dana-Farber/Massachusetts General Hospital, Inc

Boston, Massachusetts, 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

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