Study of Oral LOXO-783 Alone or With Other Cancer Drugs for Advanced Breast Cancer and Solid Tumors With PIK3CA H1047R Mutation

What this Trial Is About

Researchers are studying the safety, side effects, and effectiveness of LOXO-783 in treating patients who have advanced breast cancer or other solid tumors with specific mutations in the PIK3CA gene. The study focuses on patients whose tumors carry the PIK3CA H1047R mutation or other approved activating mutations. This trial is a Phase 1 clinical trial sponsored by Eli Lilly and Company, aiming to determine safe dosing levels and understand how the drug works in these patients. Participants will receive LOXO-783 orally, either alone or combined with other anticancer drugs such as fulvestrant, imlunestrant, abemaciclib, aromatase inhibitors, or paclitaxel given by intravenous or intramuscular routes. The study includes several parts exploring different combinations and dose levels, with some groups receiving LOXO-783 alone and others receiving it with one or more additional therapies. Treatment is given sequentially according to the study design. Participants may take part in the study for up to 36 months or longer if their disease does not worsen. During this time, researchers will monitor safety by tracking dose-limiting toxicities and other side effects in the first 28 days of treatment. They will also assess how the drug behaves in the body and its effects on tumor response over time. Regular evaluations will include blood tests, tumor measurements, and other assessments to understand treatment impact and safety.

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors