QTX3046 in Patients with KRAS G12D Mutations

Launched by QUANTA THERAPEUTICS · May 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QTX3046 for patients with advanced solid tumors that have a specific genetic mutation known as KRAS G12D. The main goal of this study is to find out how safe QTX3046 is when given alone or with another medication called cetuximab. The trial is currently looking for participants aged 65 to 74 who have already received at least one previous treatment for their cancer. To join, patients must have tumors that can be measured and have been confirmed to have the KRAS G12D mutation through specific testing.

If you or a loved one qualifies for this study, participants can expect to receive close medical care throughout the trial and will be monitored for any side effects or reactions to the treatment. It's important to note that individuals with certain health issues, such as active brain metastasis or significant heart problems, may not be eligible to participate. This trial could provide valuable information on a potential new treatment option for those facing advanced solid tumors with this specific genetic mutation.

Gender

ALL

Eligibility 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