A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

Launched by ALTEROME THERAPEUTICS, INC. · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ALTA3263 for adults with advanced solid tumors that have specific changes in the KRAS gene. These tumors include types of cancer such as pancreatic cancer, non-small cell lung cancer, and colorectal cancer. The main goal of the study is to see how safe ALTA3263 is and how well patients can tolerate it. The trial is currently looking for participants who have already tried other treatments but have not had success or could not continue those therapies.

To be eligible for this trial, participants must have a confirmed diagnosis of a solid tumor with a KRAS mutation and have cancer that cannot be surgically removed or has spread to other parts of the body. They should also be in good overall health, as defined by a specific performance scale. Participants will take ALTA3263 and will be monitored closely for any side effects. This trial will help researchers understand if this new treatment is a safe option for patients with these challenging types of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
• • Unresectable or metastatic disease.
• • Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • Adequate organ function
• Exclusion Criteria:
• • Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
• • Known condition that prohibits the ability to swallow or absorb an oral medication.
• • Other inclusion/exclusion criteria may apply.