Actively Recruiting
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Led by Regor Pharmaceuticals Inc. · Updated on 2026-04-21
63
Participants Needed
3
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
NEXT Houston
Houston, Texas, United States, 77054
Actively Recruiting
2
NEXT San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
3
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sarah Wheeler
CONTACT
R
Regor Pharmaceuticals Central Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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