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RECRUITING
NCT07524322
PHASE1

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

Sponsor: Regor Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-06

Completion Date

2028-10

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

DRUG

RGT-490

Oral tablets

Locations (5)

START Los Angeles

Los Angeles, California, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Houston

Houston, Texas, United States

NEXT San Antonio

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States