Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors (NCT07524322) | Clinical Trial Compass
RecruitingPhase 1
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
United States63 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose limiting toxicities (DLTs)
Timeframe: 4 weeks (1 cycle)
2
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Every cycle (4-week cycles) until study discontinuation, approximately 12 months