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
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