QTX3544 treatment for advanced solid tumors with KRAS G12V mutations
A Phase 1 Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of QTX3544 in Patients With Advanced Solid Tumors With KRAS G12V Mutations
This study is testing a new treatment called QTX3544 for people with advanced solid tumors that have a specific KRAS G12V mutation to see if it can help shrink their tumors, either on its own or with another drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 237 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Quanta Therapeutics Industry-sponsored |
| Drugs / interventions | cetuximab |
| Locations | 6 sites (Grand Rapids, Michigan and 5 other locations) |
| Trial ID | NCT06715124 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety, tolerability, and anti-tumor activity of QTX3544, both as a standalone treatment and in combination with cetuximab, in patients with advanced solid tumors harboring KRAS G12V mutations. Participants must have pathologically confirmed malignancies and measurable disease as defined by RECIST v1.1. The study aims to assess the effectiveness of this novel therapeutic approach in a population that has previously undergone systemic therapy.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors that have KRAS G12V 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 advanced solid tumors that have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting KRAS mutations have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12V 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 5 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)
- South Texas Accelerated Research Therapeutics Mountain Region, LLC — West Valley 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.