Testing QTX3046 for patients with KRAS G12D mutations
A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of QTX3046 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
PHASE1 · Quanta Therapeutics · NCT06428500
This study is testing a new drug called QTX3046 to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Quanta Therapeutics (industry) |
| Drugs / interventions | cetuximab |
| Locations | 5 sites (Grand Rapids, Michigan and 4 other locations) |
| Trial ID | NCT06428500 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety and tolerability of QTX3046, both as a standalone treatment and in combination with cetuximab, for patients with advanced solid tumors harboring KRAS G12D mutations. Participants must have a documented malignancy and measurable disease, having previously undergone at least one systemic therapy. The study aims to gather initial data on the drug's effects and potential benefits for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically documented advanced solid tumors that have KRAS G12D mutations and have received at least one prior systemic therapy.
Not a fit: Patients with active brain metastasis, significant cardiovascular disease, or those who have previously been treated with a KRAS inhibitor 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 mutations in advanced solid tumors.
How similar studies have performed: While this approach is novel in targeting KRAS G12D mutations specifically, similar studies targeting KRAS mutations have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutations 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 one prior systemic therapy. * Evaluable and measurable disease per RECIST v1.1. * Part 2 and 3: Measurable disease per RECIST v1.1 Exclusion Criteria: * Active brain metastasis or carcinomatous meningitis * Significant cardiovascular disease * Active infection requiring intravenous (IV) antibiotics * Prior treatment with a KRAS inhibitor Other protocol-defined Inclusion/Exclusion Criteria may apply
Where this trial is running
Grand Rapids, Michigan and 4 other locations
- South Texas Accelerated Research Therapeutics, LLC Midwest — Grand Rapids, Michigan, United States (RECRUITING)
- Duke Cancer Center — Durham, North Carolina, United States (RECRUITING)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- South Texas Accelerated Research Therapeutics, LLC San Antonio — San Antonio, Texas, United States (RECRUITING)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Quanta Therapeutics Clinical Trials
- Email: clinicaltrials@quantatx.com
- Phone: 415-599-3892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor