Breast Cancer study: RGT-490
Official title Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07524322
What this study is testing
What is RGT-490?
RGT-490 is an investigational oral tablet being studied as a potential treatment for breast cancer and other solid tumors with PI3KCA alterations.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether RGT-490 is safe and how it behaves in the body. It also looks at whether it can slow tumor growth.
- Who it's for
- You may be able to join if you are an adult with advanced breast, ovarian, endometrial, cervical, or other solid tumors that have a PIK3CA mutation and cannot be cured with current treatments.
- What's involved
- You will take RGT-490 by mouth. The study will monitor your health with regular visits and tests to check safety and how the drug works.
- Time commitment
- The study lasts several months, with multiple clinic visits for medication, blood tests, and imaging to track progress.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Unresolved clinically significant toxicities from prior anticancer therapy
- History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.