Testing QTX3034 for patients with KRAS G12D mutation in solid tumors

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

This study is testing a new treatment called QTX3034, alone and with another drug, to see if it can help patients with solid tumors that have a specific KRAS G12D mutation and haven't responded to other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Quanta Therapeutics (industry)
• Drugs / interventions: cetuximab
• Locations: 14 sites (Los Angeles, California and 13 other locations)
• Trial ID: NCT06227377 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety and tolerability of QTX3034, both as a standalone treatment and in combination with cetuximab, for patients with solid tumors harboring the KRAS G12D mutation. Participants must have advanced malignancies that have not responded to at least one prior systemic therapy. The study aims to assess the effectiveness of these treatments in managing the disease while monitoring for any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced solid tumors that have the KRAS G12D mutation and have undergone at least one prior systemic therapy.

Not a fit: Patients who have previously received treatment with a KRAS inhibitor or have active brain metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS G12D mutated solid tumors.

How similar studies have performed: While the approach of targeting KRAS mutations is gaining traction, this specific combination of QTX3034 and cetuximab is novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 13 other locations

• UCLA Hematology/Oncology — Los Angeles, California, United States (RECRUITING)
• Sarah Cannon Research Institute (SCRI) — Denver, Colorado, United States (RECRUITING)
• Yale Cancer Center — New Haven, Connecticut, United States (RECRUITING)
• Florida Cancer Specialists — Sarasota, Florida, United States (RECRUITING)
• Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
• NYU Langone Health — New York, New York, United States (RECRUITING)
• Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
• Duke University — Durham, North Carolina, United States (RECRUITING)
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (RECRUITING)
• SCRI- Nashville — Nashville, Tennessee, United States (RECRUITING)
• MD Anderson — Houston, Texas, United States (RECRUITING)
• START San Antonio, LLC — San Antonio, Texas, United States (RECRUITING)
• University of Utah, Huntsman Cancer Center — Salt Lake City, Utah, United States (RECRUITING)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Quanta Therapeutics Clinical Trials

Conditions: Solid Tumors