QTX3034 in Patients With KRAS G12D Mutation

Last updated: December 23, 2025
Sponsor: Quanta Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Solid Tumors

Treatment

Cetuximab

QTX3034

Clinical Study ID

NCT06227377
QTX3034-001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically documented, locally advanced or metastatic malignancy with KRAS G12Dmutation identified through molecular testing (NGS- or PCR-based) with a ClinicalLaboratory 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

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

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Cetuximab
Phase: 1
Study Start date:
February 05, 2024
Estimated Completion Date:
April 01, 2027

Connect with a study center

  • UCLA Hematology/Oncology

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCLA Hematology/Oncology

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute (SCRI)

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sarah Cannon Research Institute (SCRI)

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10461
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Active - Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Stephenson Cancer Center

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Active - Recruiting

  • SCRI- Nashville

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI- Nashville

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • START San Antonio, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • MD Anderson

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • START San Antonio, LLC

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • University of Utah, Huntsman Cancer Center

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • University of Utah, Huntsman Cancer Center

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Active - Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • NEXT Oncology Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

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