QTX3034 in Patients With KRAS G12D Mutation

A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: QTX3034; Combination product: Cetuximab

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Quanta Therapeutics Clinical Trials; Phone Number: 415-599-3892; Email: clinicaltrials@quantatx.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics
      • Contact: Isabel Jimenez, RN, MSN; Phone Number: 210-593-5265; Email: isabel.jimenez@startsa.com
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah, Huntsman Cancer Center
      • Contact: Susan Sharry; Phone Number: 801-585-3453; Email: susan.sharry@hci.utah.edu
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • NEXT Oncology Virginia
      • Contact: Blake Patterson; Phone Number: 703-783-4505; Email: bpatterson@nextoncology.com

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a: QTX3034 monotherapy dose-escalation; QTX3034 will be administered at protocol defined dose based on cohort assignment	Drug: QTX3034; QTX3034 will be administered at protocol defined dose
Experimental: Part 1b: QTX3034 combination with cetuximab dose-escalation; QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment	Drug: QTX3034; QTX3034 will be administered at protocol defined dose; Combination product: Cetuximab; Cetuximab will be administered at protocol defined dose.
Experimental: Part 2: QTX3034 monotherapy dose-expansion; QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment	Drug: QTX3034; QTX3034 will be administered at protocol defined dose
Experimental: Part 3: QTX3034 combination with cetuximab dose-expansion; QTX3034 will be administered at protocol defined dose in combination with cetuximab based on cohort assignment	Drug: QTX3034; QTX3034 will be administered at protocol defined dose; Combination product: Cetuximab; Cetuximab 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 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
Number of participants with Treatment-emergent Adverse Events (TEAEs)	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	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QTX3034 pharmacokinetic parameters in plasma	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).	up to 2 years
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
Duration of response (DOR)	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.	up to 2 years

Collaborators and Investigators

• Sponsor: Quanta Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: QTX3034-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No