RecruitingRecruiting
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
NCT07524322 · Regor Pharmaceuticals Inc.
In plain English
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Official title
A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers
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.
Eligibility criteria
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).
Study design
Enrollment target: 63 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04
Estimated completion: 2028-10
Last updated: 2026-04-21
Interventions
Drug: RGT-490
Primary outcomes
- • Incidence of dose limiting toxicities (DLTs) (4 weeks (1 cycle))
- • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Every cycle (4-week cycles) until study discontinuation, approximately 12 months)
Sponsor
Regor Pharmaceuticals Inc. · industry
Contacts & investigators
ContactSarah Wheeler · contact · Sarah.Wheeler@regor.com · 857-331-3898
ContactRegor Pharmaceuticals Central Office · contact · RGT-490-101@regor.com · 617-315-9070
All locations (3)
NEXT HoustonRecruiting
Houston, Texas, United States
NEXT San AntonioRecruiting
San Antonio, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States