RecruitingPhase 1NCT07300150

A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors

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


Sponsor

PAQ Therapeutics, Inc.

Enrollment

195 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called PT0511 in people with advanced or metastatic solid tumors that have a mutation or amplification in a gene called KRAS. KRAS is a gene that, when abnormal, can drive cancer growth, and researchers are looking for new ways to target it. **You may be eligible if...** - You are 18 or older - You have an advanced or metastatic solid tumor confirmed by biopsy - Your tumor has a KRAS mutation or amplification, confirmed by a certified lab test - You have received at least one prior treatment but no more than a certain number of prior therapies - You are in reasonably good overall health **You may NOT be eligible if...** - Your tumor does not have a KRAS mutation or amplification - You have not received any prior treatment, or have received too many prior lines of therapy - You have untreated brain metastases or other serious health conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPT0511

Intravenous infusion.

DRUGCetuximab

Intravenous infusion.


Locations(5)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07300150


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