drugset / Trial / NCT07524322

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

NCT07524322 ↗

Phase 1 Recruiting 63 enrolled Regor Pharmaceuticals Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2026-06
Primary completion
2028-04
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject RGT-490 Unknown — —