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NCT07524322PHASE1Recruiting

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

Regor Pharmaceuticals Inc.

Start Date

6/1/2026

Completion Date

10/1/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * Diabetes mellitus requiring anti-hyperglycemic medication. * Prior treatment with PI3Kα inhibitors * Symptomatic, untreated, or uncontrolled central nervous system metastases. * Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment. * Unresolved clinically significant toxicities from prior anticancer therapy * History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).

Interventions

DRUG

RGT-490

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Conditions

Breast CancerOvarian CancerEndometrial CancerPIK3CA MutationHER2- Negative Breast CancerAdvanced Breast CancerUnresectable Solid TumorHormone Receptor Positive TumorCervical Cancer

Locations

START Los Angeles

Los Angeles, California 90025

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Houston

Houston, Texas 77054

United States

NEXT San Antonio

San Antonio, Texas 78229

United States

NEXT Virginia

Fairfax, Virginia 22031

United States