QTX3034 in Patients With KRAS G12D Mutation

Phase 1

Recruiting

• Conditions: Solid Tumors
• Interventions: Drug: QTX3034; Combination Product: Cetuximab

• Registration Number: NCT06227377
• Lead Sponsor: Quanta Therapeutics

Brief Summary

Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-26
• Study Start: 2024-02-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation 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 1 prior systemic therapy
• Evaluable or Measurable disease per RECIST 1.1.
• Parts 2 and 3: Measurable disease per RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate organ function

Exclusion Criteria

• Prior treatment with a KRAS inhibitor
• Active brain metastases or carcinomatous meningitis
• History of other malignancy within 2 years
• Significant cardiovascular disease
• Disease or disorder that may pose a risk to patient's safety

Other protocol-defined Inclusion/Exclusion Criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1b: QTX3034 combination with cetuximab dose-escalation	Cetuximab	QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 2: QTX3034 monotherapy dose-expansion	QTX3034	QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 3: QTX3034 combination with cetuximab dose-expansion	QTX3034	QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 1b: QTX3034 combination with cetuximab dose-escalation	QTX3034	QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment
Part 1a: QTX3034 monotherapy dose-escalation	QTX3034	QTX3034 will be administered at protocol defined dose based on cohort assignment
Part 3: QTX3034 combination with cetuximab dose-expansion	Cetuximab	QTX3034 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 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
Number of participants with Treatment-emergent Adverse Events (TEAEs)	up to 2 years	Defined 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

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	up to 2 years	Duration of response (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.
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.
QTX3034 pharmacokinetic parameters in plasma	up to 2 years	Plasma concentration data for QTX3034 will be used to evaluate PK parameters such as maximum concentration (Cmax), minimum concentration (Cmin), time to attain Cmax (Tmax), area under the concentration-time curve (AUC), elimination half-life (t1⁄2).

Trial Locations

Locations (14)

UCLA Hematology/Oncology; 🇺🇸 Los Angeles, California, United States

Sarah Cannon Research Institute (SCRI); 🇺🇸 Denver, Colorado, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

SCRI- Nashville; 🇺🇸 Nashville, Tennessee, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

START San Antonio, LLC; 🇺🇸 San Antonio, Texas, United States

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

NEXT Oncology Virginia; 🇺🇸 Fairfax, Virginia, United States