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RecruitingInterventionalPhase 1

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

NCT ID: NCT06227377Sponsor: Quanta TherapeuticsLast updated: 2026-04-27

Summary

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

Arms & interventions

  • DrugQTX3034

    QTX3034 will be administered at protocol defined dose

  • Combination ProductCetuximab

    Cetuximab will be administered at protocol defined dose.

Outcome measures

Primary

  • 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

    Time frame: 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

    Time frame: up to 2 years

Secondary

  • QTX3034 pharmacokinetic parameters in plasma

    Time frame: up to 2 years

  • Objective response rate (ORR)

    Time frame: up to 2 years

  • Duration of response (DOR)

    Time frame: up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (14)

UCLA Hematology/Oncology

Los Angeles, California, 90095

Recruiting

Sarah Cannon Research Institute (SCRI)

Denver, Colorado, 80218

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06511

Recruiting
Ingrid Palma · Contact

Florida Cancer Specialists

Sarasota, Florida, 34232

Recruiting
Carly Taylor · Contact

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

NYU Langone Health

New York, New York, 10016

Recruiting
DL_Phase1Screening · Contact

Montefiore Medical Center

The Bronx, New York, 10461

Recruiting
Gunnar Lauer · Contact

Duke University

Durham, North Carolina, 27710

Recruiting
Sabina Wlazlo · Contact

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Recruiting
Michelle Johnson · Contact
Lana Seibert · Contact

SCRI- Nashville

Nashville, Tennessee, 37203

Recruiting

MD Anderson

Houston, Texas, 77030

Recruiting

START San Antonio, LLC

San Antonio, Texas, 78229

Recruiting
Isabel Jimenez, RN, MSN · Contact

University of Utah, Huntsman Cancer Center

Salt Lake City, Utah, 84112

Recruiting

NEXT Oncology Virginia

Fairfax, Virginia, 22031

Recruiting
Blake Patterson · Contact