NCT07524322RecruitingPhase 1
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 21 Jul 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Regor Pharmaceuticals Inc.
- NCT number
- NCT07524322
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 63
- From 21 Jul 2026 to the primary completion date, 30 Apr 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Diabetes mellitus requiring anti-hyperglycemic medication.
Other
- Symptomatic, untreated, or uncontrolled central nervous system metastases.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| NEXT Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| START - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| NEXT San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.