NCT07524322 · Regor Pharmaceuticals Inc.
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
What this study is about
This is a phase 1/1b, where both patients and doctors know the treatment given, conducted at multiple hospitals study consisting of sequential parts designed to evaluate the safety, tolerability, and effects how the drug moves through the body (PK) profile, and antitumor activity of RGT-490, an experimental taken by mouth 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.
View original scientific 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. 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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Los Angeles, California
- Houston, Texas
- San Antonio, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations