RGT-490 for advanced cancers with a PIK3CA gene change, including breast cancer
Tests RGT-490, an oral drug, in adults with advanced PIK3CA-mutated solid tumors.
Plain-language title generated from the registry record
Registry title: Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Key facts
- Where
- Fairfax, Houston, Los Angeles, Pittsburgh, and San Antonio, United StatesSee the 6 sites
- Phase
- Phase 1
Where in United States
- NEXT VirginiaFairfax, United StatesTaking people
- NEXT HoustonHouston, United StatesTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- START - Los AngelesLos Angeles, United StatesTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesTaking people
- NEXT San AntonioSan Antonio, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regor Pharmaceuticals Inc.
- Trial code
- NCT07524322
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Prior treatment with PI3Kα inhibitors; 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); Diabetes mellitus requiring anti-hyperglycemic medication; Symptomatic, untreated, or uncontrolled central nervous system metastases.