NCT07524322 Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
| NCT ID | NCT07524322 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Regor Pharmaceuticals Inc. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2026-06 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 63 participants in total. It began in 2026-06 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07524322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07524322 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07524322 currently recruiting?
Yes, NCT07524322 is actively recruiting participants. Contact the research team at Sarah.Wheeler@regor.com for enrollment information.
Where is the NCT07524322 trial being conducted?
This trial is being conducted at Los Angeles, United States, Houston, United States, Houston, United States, San Antonio, United States and 1 additional location.
Who is sponsoring the NCT07524322 clinical trial?
NCT07524322 is sponsored by Regor Pharmaceuticals Inc.. The trial plans to enroll 63 participants.
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