QTX3544 in Patients with Advanced Solid Tumors with KRAS G12V Mutations

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QTX3544; Combination Product: Cetuximab

• Registration Number: NCT06715124
• Lead Sponsor: Quanta Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-04
• Status Verified: 2025-01
• Study Start: 2025-01-14
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-01-02
• Study Completion: 2029-01-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 237

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: QTX3544 monotherapy dose expansion	QTX3544	QTX3544 will be administered at protocol defined dose based on cohort assignment
Part 1b: QTX3544 dose escalation in combination with cetuximab	Cetuximab	QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 3: QTX3544 dose expansion in combination with cetuximab	QTX3544	QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 3: QTX3544 dose expansion in combination with cetuximab	Cetuximab	QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 1a: QTX3544 monotherapy dose escalation	QTX3544	QTX3544 will be administered at protocol defined dose based on cohort assignment
Part 1b: QTX3544 dose escalation in combination with cetuximab	QTX3544	QTX3544 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve (AUC) of QTX3544	up to 2 years	Plasma concentration data for QTX3544 will be used to evaluate the area under the concentration-time curve (AUC) of QTX3544.
Peak plasma concentration of QTX3544 (Cmax)	up to 2 years	Plasma concentration data for QTX3544 will be used to evaluate peak plasma concentration (Cmax) of QTX3544.
Objective response rate (ORR)	up to 2 years	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.
Duration of response (DoR)	up to 2 years	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.

Trial Locations

Locations (4)

Huntsman Cancer Institute, University of Utah; 🇺🇸 Salt Lake City, Utah, United States

South Texas Accelerated Research Therapeutics, LLC Midwest; 🇺🇸 Grand Rapids, Michigan, United States

South Texas Accelerated Research Therapeutics, LLC San Antonio; 🇺🇸 San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics Mountain Region, LLC; 🇺🇸 West Valley City, Utah, United States