Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Sponsored by Regor Pharmaceuticals Inc.
About this study
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.
Where this study is enrolling (2)
- I'm interested
NEXT Houston
Houston, Texas
- Call 877-632-6789
The University of Texas MD Anderson Cancer Center
Houston, Texas
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Who can participate
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).
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Trial data sourced from ClinicalTrials.gov.