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RLY-2608

Clinical trials are studying RLY-2608 in people with PIK3CA-related overgrowth and malformations, and in people with PIK3CA-mutated advanced breast cancer. These studies look at safety, tolerability, and how well RLY-2608 works in different patient groups.

Table of contents

Clinical trials overview

These studies are testing RLY-2608 in two different disease areas: PIK3CA-related overgrowth spectrum and malformations, and PIK3CA-mutated hormone-receptor positive, HER2-negative advanced or metastatic breast cancer.[1][2]

Both trials are listed as authorised, which means they have approval to run.[1][2] One study is Phase 2 and the other is Phase 3.[1][2]

The Phase 2 study, NCT06789913, is titled RLY-2608-201-Ph2 Study of RLY-2608 in PROS and PIK3CA Driven Malformations.[1] It is an interventional trial, which means participants receive a study treatment and the researchers observe the results.[1]

This study includes 347 participants and is looking at people with PIK3CA-related overgrowth spectrum and malformations driven by a PIK3CA mutation.[1] The brief summary says Parts 1 and 2 aim to find the recommended Phase 2 dose for Groups 1, 2, and 3 and to check safety and tolerability.[1]

In Part 3, the study compares RLY-2608 with placebo and looks at volumetric response rate at Week 24.[1] A placebo is a treatment with no active study drug, used as a comparison.[1]

Phase 3 study in advanced breast cancer

The Phase 3 study, NCT06982521, is comparing RLY-2608 plus fulvestrant with capivasertib plus fulvestrant in people with PIK3CA-mutated, hormone-receptor positive, HER2-negative locally advanced or metastatic breast cancer.[2]

This is a larger trial with 540 participants and is also interventional.[2] The study is designed to compare how well the treatments work, using progression-free survival as the main outcome.[2]

Progression-free survival means the time from randomization until the cancer gets worse on scans, or the person dies from any cause.[2] The summary says the trial will compare efficacy in the overall group and in kinase populations by BICR, which means blinded independent central review.[2]

How the trials measure results

The Phase 2 study measures safety profile by looking at dose-limiting toxicities, side effects, serious side effects, vital signs, ECGs, and safety laboratory tests.[1] A dose-limiting toxicity is a side effect that may stop a dose from being used as planned.[1]

The same study also measures whether the affected tissue changes in size, using volumetric response at Week 24.[1] This is important in overgrowth conditions because the size of the affected area is part of the disease burden.[1]

The Phase 3 breast cancer study uses RECIST v1.1 for checking radiographic progression, which means cancer growth seen on imaging scans.[2] The main question is whether RLY-2608 plus fulvestrant can delay progression better than the comparison treatment.[2]

Who may take part

People may be considered for the Phase 2 study if they have PIK3CA-related overgrowth spectrum or PIK3CA-driven malformations.[1] The study title and summary show that the trial is focused on these mutation-driven overgrowth conditions.[1]

People may be considered for the Phase 3 study if they have PIK3CA-mutated HR+/HER2- locally advanced or metastatic breast cancer.[2] The trial is built for a specific cancer group, so not every person with breast cancer would match the study.[2]

Key patient terms

Interventional study means the research team gives a treatment and watches what happens.[1][2]

Randomization means participants are assigned to treatment groups by chance, which helps make the comparison fair.[2]

Fulvestrant is part of the breast cancer study treatment plan, and the trial compares it with another treatment combination.[2]

Placebo is used in the Phase 2 overgrowth study as a comparison with the active study drug in Part 3.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06789913 Phase 2 PIK3CA Related Overgrowth Spectrum and Malformations Driven by PIK3CA Mutation Authorised 347
NCT06982521 Phase 3 PIK3CA-mutant HR+/HER2- locally advanced or metastatic breast cancer Authorised 540

FAQ

  • What is being studied in RLY-2608 trials? The trials are studying RLY-2608 in two main settings: PIK3CA-related overgrowth spectrum and malformations, and PIK3CA-mutated hormone-receptor positive, HER2-negative advanced or metastatic breast cancer.
  • Who can take part in these trials? People may be eligible if they have PIK3CA-related overgrowth or malformations, or if they have PIK3CA-mutated HR+/HER2- locally advanced or metastatic breast cancer. Each study has its own rules for who can join.
  • What phases are the RLY-2608 studies? One study is Phase 2 and another is Phase 3. Phase 2 focuses on dose finding, safety, and early effectiveness, while Phase 3 compares treatments in a larger group.
  • What are the trials trying to measure? The Phase 2 study measures safety, dose selection, and volumetric response, which means change in the size or volume of the affected area. The Phase 3 study measures progression-free survival, which is the time before the cancer gets worse or the person dies.
  • Are these trials still open? Both trials are listed as authorised. That means they have been approved to run.

Ongoing Clinical Trials on RLY-2608

  • A Study Comparing RLY-2608 and Fulvestrant with Capivasertib and Fulvestrant for Patients with PIK3CA-Mutant Hormone Receptor Positive, HER2-Negative Advanced Breast Cancer

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark France +8

  • Study of RLY-2608 for Adults and Children with PIK3CA-Related Overgrowth and Malformations

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Ireland Italy Norway +1

Glossary

  • PIK3CA: A gene that can have changes, called mutations, which may drive some overgrowth conditions and some cancers.
  • PIK3CA-related overgrowth spectrum: A group of conditions where body tissues grow more than usual because of a PIK3CA mutation.
  • Malformations: Changes in the normal shape or development of body parts.
  • Hormone-receptor positive: A type of breast cancer that grows in response to certain hormones.
  • HER2-negative: Breast cancer that does not have high levels of the HER2 protein.
  • Locally advanced: Cancer that has grown beyond its original area but has not clearly spread to distant parts of the body.
  • Metastatic: Cancer that has spread to other parts of the body.
  • Phase 2: A trial phase that often looks at safety, dose, and early signs of benefit.
  • Phase 3: A larger trial phase that compares treatments and checks how well they work.
  • Progression-free survival: The length of time during and after treatment that a disease does not get worse.
  • Volumetric response: A change in the volume or size of an affected area, used here to measure response in overgrowth or malformation.
  • Randomization: Assigning participants to treatment groups by chance.

References