Recruiting

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

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.

ClinicalTrials.gov IDNCT07524322

PhasePHASE1

Enrollment63

SponsorRegor Pharmaceuticals Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Drug: RGT-490 — Oral tablets

Primary outcomes

Incidence of dose limiting toxicities (DLTs) (4 weeks (1 cycle))
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Every cycle (4-week cycles) until study discontinuation, approximately 12 months)

Eligibility information

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).

Study 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

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.