Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Sponsor: Regor Pharmaceuticals Inc.
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
Conditions
Interventions
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