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

Recruiting now · Phase 1

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

In brief

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.

Key facts

Study ID

NCT07524322

Run by

Regor Pharmaceuticals Inc.

People needed

63

Starts

2026-06-01

Expected to finish

2028-10-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• START Los Angeles — Los Angeles, California, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Houston — Houston, Texas, United States (enrolling)
• NEXT San Antonio — San Antonio, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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