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RLY-2608-201-Ph2 Study of RLY-2608 in PROS and PIK3CA Driven Malformations
EU CTIS ID: 2024-518895-30-00
What this study is testing
Parts 1 and 2 - To determine the RP2D(s) for Groups 1, 2, and 3 - To determine the safety and tolerability of RLY-2608 Part 3 - To determine the efficacy of RLY-2608 compared to placebo as assessed by volumetric response rate
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Lansky (<16 yo) or Karnofsky (≥16 yo) performance status of ≥50.
- The participant must have a clinical diagnosis of PROS or a malformation within the ISSVA classifications
- 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 lesion or blood
- Agree to provide archived lesional fluid and/or tissue or be willing to undergo pretreatment lesional biopsy (if considered safe and medically feasible) to assess PIK3CA status
You likely can't join if
- Received disease-directed therapy prior to first dose of study drug (systemic therapy 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).
- History of hypersensitivity to PI3K inhibitors.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Clinically significant, uncontrolled cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
- Canada
- United Kingdom
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, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia; Canada; United Kingdom. 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 EU CTIS; the study team decides eligibility.