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Study of QTX3034 for KRAS G12D-Mutated Solid Tumors

This study is testing a new drug called QTX3034, given alone or with cetuximab, for people with advanced solid tumors that have a specific genetic change called a KRAS G12D mutation. To join, you must be at least 18 years old and have a solid tumor that has this specific mutation, confirmed by a special test. You should also have tried at least one other treatment before. The main goals are to see how safe QTX3034 is and what side effects it might cause. This study plans to include about 250 participants. The current recruitment status is unclear.

Study design
This is a Phase 1 interventional study, meaning it's an early-stage trial to test safety. It plans to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for treatment-emergent adverse events (side effects) for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06227377

QTX3034 in Patients With KRAS G12D Mutation

Recruiting
PHASE1Ages 18+InterventionalTreatment
Quanta Therapeutics
~250 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:QTX3034Cetuximab

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose Limiting Toxicities (DLTs)
Measured over up to 21 days
+1 more outcome measured

Conditions

Solid Tumors

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NCT06227377

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Floridastudy coordinator listed

    Recruiting

  • MD Anderson

    Houston, Texasstudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Montefiore Medical Center

    The Bronx, New Yorkstudy coordinator listed

    Recruiting

  • NEXT Oncology Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • NYU Langone Health

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Sarah Cannon Research Institute (SCRI)

    Denver, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Quanta Therapeutics Clinical Trials
[email protected]
415-599-3892
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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