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New treatment option for PIK3CA-Related Overgrowth Spectrum (PROS)
Official title A Phase 2 Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, in Adults and Children With PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation (The ReInspire Study)
ClinicalTrials.gov ID: NCT06789913
What this study is testing
What is RLY-2608?
RLY-2608 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pik3ca-related overgrowth spectrum (pros).
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 is a 3-part Phase 2 randomized study evaluating the safety and efficacy of the mutant-selective PI3Kα inhibitor, zovegalisib (RLY-2608), in adults and children with PIK3CA Related Overgrowth Spectrum (PROS) and malformations driven by PIK3CA mutation. Part 1 is a dose selection, Part 2 is a basket design with exploratory single-arm cohorts for various subpopulations of participants, and Part 3 is randomized, double-blinded study vs placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classification.
- One or more documented activating PIK3CA mutation(s) that are targeted by selective PI3Kα inhibitors in lesional tissue and/or cell-free DNA from the...
- Lansky (\<16 yo) or Karnofsky (≥16 yo) performance status of ≥50.
- Agree to provide archived lesional fluid and/or tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically...
You likely can't join if
- Known hypersensitivity to RLY-2608.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Clinically significant, uncontrolled cardiovascular disease
- Received disease-directed therapy prior to the first dose of study drug:
- Systemic therapy or antibody within 5 half-lives of the therapy.
- Local therapy including radiation, surgery, or other procedures within 28 days; lesion(s) must have demonstrated progression after the procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
+ 12 more site(s).
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 - 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, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Aurora, Colorado, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.