QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

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

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Combination product: Cetuximab; Drug: QTX3544

• Study Type: Interventional
• Enrollment (Estimated): 237
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Sarah Cannon Research Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists & Research Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • South Texas Accelerated Research Therapeutics, LLC Midwest
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics, LLC San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute, University of Utah
    • West Valley City, Utah, United States, 84119
      • South Texas Accelerated Research Therapeutics Mountain Region, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a: QTX3544 monotherapy dose escalation; QTX3544 will be administered at protocol defined dose based on cohort assignment	Drug: QTX3544; QTX3544 will be administered at protocol defined dose.
Experimental: Part 1b: QTX3544 dose escalation in combination with cetuximab; QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment	Combination product: Cetuximab; Cetuximab will be administered at protocol defined dose.; Drug: QTX3544; QTX3544 will be administered at protocol defined dose.
Experimental: Part 2: QTX3544 monotherapy dose expansion; QTX3544 will be administered at protocol defined dose based on cohort assignment	Drug: QTX3544; QTX3544 will be administered at protocol defined dose.
Experimental: Part 3: QTX3544 dose expansion in combination with cetuximab; QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment	Combination product: Cetuximab; Cetuximab will be administered at protocol defined dose.; Drug: QTX3544; QTX3544 will be administered at protocol defined dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Treatment-emergent Adverse Events (TEAEs)	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.	up to 2 years
Number of participants with Dose Limiting Toxicities (DLTs)	DLTs will be defined as the occurrence of any of the toxicities as described in the protocol.	up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1.	up to 2 years
Area under the plasma concentration-time curve (AUC) of QTX3544	Plasma concentration data for QTX3544 will be used to evaluate the area under the concentration-time curve (AUC) of QTX3544.	up to 2 years
Peak plasma concentration of QTX3544 (Cmax)	Plasma concentration data for QTX3544 will be used to evaluate peak plasma concentration (Cmax) of QTX3544.	up to 2 years
Duration of response (DoR)	DoR is defined as the time between first evidence of objective response and disease progression (as measured by RECIST 1.1) or death, whichever occurs earlier, in subjects who achieve CR or PR.	up to 2 years

Collaborators and Investigators

• Sponsor: Quanta Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2029

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab
• Other Study ID Numbers: QTX3544-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No