RecruitingPhase 1NCT07524322

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

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

Sponsor

Regor Pharmaceuticals Inc.

Enrollment

63 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Ovarian Cancer Cervical Cancer Endometrial Cancer HER2-negative Breast Cancer Advanced Breast Cancer PIK3CA Mutation Unresectable Solid Tumor Hormone Receptor Positive Tumor

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called RGT-490 for people with advanced breast cancer, breast cancer, and other related conditions. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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