QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

NCT06715124 · tracked via the Priya Life Science USA tracker

Sponsor

Quanta Therapeutics

Phase

Phase 1

Started

2025-01-14

Last updated

2026-03-02

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

QTX3544Cetuximab

QTX3544: QTX3544 will be administered at protocol defined dose.

Cetuximab: Cetuximab will be administered at protocol defined dose.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Number of participants with Treatment-emergent Adverse Events (TEAEs) — up to 2 years
Define as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab.
Number of participants with Dose Limiting Toxicities (DLTs) — up to 21 days
DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.

Trial sites (10)

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

More Quanta Therapeutics trials in the USA

QTX3046 in Patients With KRAS G12D Mutations Active, not recruiting

QTX3034 in Patients With KRAS G12D Mutation Recruiting

Other trials for the same condition

A Study of MGC028 in Participants With Advanced Solid Tumors Recruiting

A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. Recruiting

A Study to Evaluate Claudin 18.2-Directed ADC LCB02A in Advanced Solid Tumors Recruiting

A Clinical Study of YL205 in Patients With Advanced Solid Tumors Recruiting

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06715124 on ClinicalTrials.gov ↗ ← All trials in the USA