QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

Phase 1 study to determine the safety, tolerability, and anti-tumor activity of QTX3544 as a single agent or in combination with cetuximab.

Key facts

Study ID

NCT06715124

Run by

Quanta Therapeutics

People needed

237

Starts

2025-01-14

Expected to finish

2029-01-02

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V 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.

You may not qualify if…

• Active brain metastasis or carcinomatous meningitis
• Significant cardiovascular disease
• Active infection requiring intravenous (IV) antibiotics
• Prior treatment with a KRAS inhibitor
• Other protocol-defined Inclusion/Exclusion Criteria may apply

Where it is running

• Sarah Cannon Research Institute — Denver, Colorado, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Florida Cancer Specialists & Research Institute — Sarasota, Florida, United States
• South Texas Accelerated Research Therapeutics, LLC Midwest — Grand Rapids, Michigan, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• South Texas Accelerated Research Therapeutics, LLC San Antonio — San Antonio, Texas, United States
• Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States
• South Texas Accelerated Research Therapeutics Mountain Region, LLC — West Valley City, Utah, United States

Full record on ClinicalTrials.gov

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