Clinical Trial

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

Study acronym: PIKASSO-01
Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.
Protocol Amendment History 3 changes
critical Trial status changed: ACTIVE_NOT_RECRUITING → RECRUITING 2026-07-21
notable Enrollment increased: 193 -> 260 participants 2026-07-21
notable Trial sites expanded: 45 -> 50 locations 2026-04-21
Trial Details
NCT Number NCT05307705
Lead Sponsor Eli Lilly and Company
Conditions Breast Cancer
Enrollment 260 participants
Start Date 2022-05-11
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-20