Phase 1 Study of JZP815 Oral Capsules for Adults With Advanced or Metastatic Solid Tumors Having MAPK Pathway Alterations to Assess Safety and Antitumor Effects

What this Trial Is About

Researchers are evaluating the safety, dosage, and early antitumor effects of JZP815 in adults with advanced or metastatic solid tumors that have changes in the MAPK pathway. This phase 1, first-in-human study aims to understand how JZP815 works in this specific group of cancer patients. The study is sponsored by Jazz Pharmaceuticals and focuses on tumors with MAPK pathway alterations where current standard treatments are no longer effective or suitable. The study has two parts Part A focuses on finding the safest and most tolerable dose of JZP815, assessing how the drug behaves in the body, and determining the best dose for further testing. Participants will receive oral capsules of JZP815 twice daily, about 12 hours apart, starting at 20 mg. Part B will use this recommended dose to further explore the drugs antitumor activity in various tumor types with applicable MAPK mutations. Dose adjustments and additional dosing schedules may be based on study findings. Participants will undergo regular monitoring for safety and effectiveness, including blood tests to track changes in blood components, liver and kidney function, heart rate, and blood pressure. Researchers will also observe any side effects or dose changes, and measure tumor response using RECIST criteria. The study follows participants from treatment start until death, withdrawal, or up to 18 months after the last participant begins treatment, ensuring careful long-term safety and activity assessment.

A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815