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Active Not RecruitingPhase 1NCT06428500

QTX3046 in Patients With KRAS G12D Mutations

Phase 1 study to determine the safety and tolerability of QTX3046 as a single agent or in combination with cetuximab.

Lead sponsor: Quanta Therapeutics•5 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Quanta Therapeutics

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic.
•Part 1: Advanced solid tumors with at least one prior systemic therapy.
•Evaluable and measurable disease per RECIST v1.1.
•Part 2 and 3: Measurable disease per RECIST v1.1

Exclusion Criteria

•Active brain metastasis or carcinomatous meningitis
•Significant cardiovascular disease
•Active infection requiring intravenous (IV) antibiotics
•Prior treatment with a KRAS inhibitor

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 25, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhasePHASE1

Enrollment240

Start dateMay 2024

Last updatedJul 25, 2025

Condition

Advanced Solid Tumor

Locations shown

South Texas Accelerated Research Therapeutics, LLC Midwest

Grand Rapids, Michigan

Duke Cancer Center

Durham, North Carolina

The University of Texas MD Anderson Cancer Center

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2025Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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