QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations

NCT06715124 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: QTX3544-201
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Area under the plasma concentration-time curve (AUC) of QTX3544

  up to 2 years

• Peak plasma concentration of QTX3544 (Cmax)

  up to 2 years

• Objective response rate (ORR)

  up to 2 years

• Duration of response (DoR)

  up to 2 years

Study Arms (4)

Part 1a: QTX3544 monotherapy dose escalation

EXPERIMENTAL

QTX3544 will be administered at protocol defined dose based on cohort assignment

Drug: QTX3544

Part 1b: QTX3544 dose escalation in combination with cetuximab

EXPERIMENTAL

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Drug: QTX3544; Combination Product: Cetuximab

Part 2: QTX3544 monotherapy dose expansion

EXPERIMENTAL

QTX3544 will be administered at protocol defined dose based on cohort assignment

Drug: QTX3544

Part 3: QTX3544 dose expansion in combination with cetuximab

EXPERIMENTAL

QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Drug: QTX3544; Combination Product: Cetuximab

Interventions

QTX3544 DRUG

QTX3544 will be administered at protocol defined dose.

Part 1a: QTX3544 monotherapy dose escalation; Part 1b: QTX3544 dose escalation in combination with cetuximab; Part 2: QTX3544 monotherapy dose expansion; Part 3: QTX3544 dose expansion in combination with cetuximab

Cetuximab COMBINATION_PRODUCT

Cetuximab will be administered at protocol defined dose.

Part 1b: QTX3544 dose escalation in combination with cetuximab; Part 3: QTX3544 dose expansion in combination with cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Quanta Therapeutics: lead

Study Sites (10)

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Florida Cancer Specialists & Research Institute

Sarasota, Florida, 34232, United States

Location

South Texas Accelerated Research Therapeutics, LLC Midwest

Grand Rapids, Michigan, 49546, United States

Location

Duke Cancer Center

Durham, North Carolina, 27705, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics, LLC San Antonio

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

South Texas Accelerated Research Therapeutics Mountain Region, LLC

West Valley City, Utah, 84119, United States

Location

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2029
• Last Updated: March 2, 2026

Record last verified: 2025-06

Locations

US (10)