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โ† Trials
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Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllRegor Pharmaceuticals Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 PI3Kฮฑ 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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What it tests

  • RGT-490
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Where

5 sites
START Los Angeles
Los Angeles, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
NEXT Houston
Houston, United States
NEXT San Antonio
San Antonio, United States
NEXT Virginia
Fairfax, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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