A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers
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.
• Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.
• Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood.
• At least 1 measurable lesion or evaluable disease per RECIST v1.1.
• An ECOG performance status of 0 or 1.
• Adequate organ function