QTX3034 in Patients With KRAS G12D Mutation

April 22, 2026 updated by: Quanta Therapeutics

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology
        • Contact:
    • Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale Cancer Center
        • Contact:
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
      • Tampa, Florida, United States, 33612
    • New York
      • New York, New York, United States, 10016
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Oklahoma
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah, Huntsman Cancer Center
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: up to 21 days
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)
Time Frame: 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
up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quanta Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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