Testing QTX3034 for patients with KRAS G12D mutation in solid tumors
Official title: A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation
Run by Quanta Therapeutics · NCT06227377 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Quanta Therapeutics Industry-sponsored |
| Drugs / interventions | cetuximab |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Status | Recruiting |
| Started | February 5, 2024 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT06227377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have previously received treatment with a KRAS inhibitor or have active brain metastases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 8 more locations
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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
- Email: clinicaltrials@quantatx.com
- Phone: 415-599-3892
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.