Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer. Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.

NCT Number	NCT07524322
Lead Sponsor	Regor Pharmaceuticals Inc.
Conditions	Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation, HER2- Negative Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor +1 more
Enrollment	63 participants
Start Date	2026-06
Primary Completion	2028-04 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2026-07-22