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Hormone Therapy

RLY-2608 + Fulvestrant for Breast Cancer

Phase 1

Recruiting

Research Sponsored by Relay Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Had previous treatment for advanced or metastatic breast cancer with specified medications

Male or female with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately every week in cycle 1 (4-week cycle), every two weeks in cycle 2 (4-week cycle), and every cycle starting with cycle 3 through end of treatment, approx 24 months

Awards & highlights

Study Summary

This trial is designed to study the maximum tolerated dose, safety, and preliminary anti-cancer activity of RLY-2608 in patients with advanced solid tumors who have a PIK3CA mutation. The trial will have two parts: a dose escalation (Part 1) and a dose expansion (Part 2).

Who is the study for?

This trial is for adults with advanced solid tumors or breast cancer that can't be removed by surgery, have worsened despite standard treatments, or who cannot tolerate such treatments. Participants must have a specific gene mutation (PIK3CA), be in good physical condition (ECOG 0-1), and not have certain health issues like uncontrolled diabetes or heart disease.Check my eligibility

What is being tested?

The study tests RLY-2608 alone and combined with fulvestrant, plus CDK4/6 inhibitors palbociclib or ribociclib in patients with hormone receptor-positive, HER2-negative advanced breast cancer. It aims to find the safest dose that works best (dose escalation) and then see how well it works at this dose (dose expansion).See study design

What are the potential side effects?

Possible side effects include high blood sugar levels, skin reactions like rash, digestive problems such as diarrhea and mouth sores. Severe allergic reactions are also possible but rare. The combination of drugs could affect heart rhythm or cause lung issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated for advanced breast cancer with specific drugs.

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I have breast cancer that cannot be surgically removed or cured, and it is hormone receptor positive and HER2 negative.

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I am fully active or can carry out light work.

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My condition hasn't improved with standard treatments, or I can't tolerate them.

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My cancer has a PIK3CA mutation.

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My cancer is confirmed to be advanced and cannot be removed by surgery.

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My cancer is advanced, cannot be surgically removed, and has a PIK3CA mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately every week in cycle 1 (4-week cycle), every two weeks in cycle 2 (4-week cycle), and every cycle starting with cycle 3 through end of treatment, approx 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately every week in cycle 1 (4-week cycle), every two weeks in cycle 2 (4-week cycle), and every cycle starting with cycle 3 through end of treatment, approx 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately every week in cycle 1 (4-week cycle), every two weeks in cycle 2 (4-week cycle), and every cycle starting with cycle 3 through end of treatment, approx 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-2608 as a single agent

Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant

Determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RLY-2608 in combination with fulvestrant and a CDK 4/6 inhibitor (palbociclib, ribociclib)

+3 more

Secondary outcome measures

Changes in circulating blood of C-peptide in RLY-2608 as a single agent

Changes in circulating blood of C-peptide in RLY-2608 in combination with fulvestrant

Changes in circulating blood of C-peptide in RLY-2608 in combination with fulvestrant and a CDK4/6 inhibitor (palbociclib, ribociclib)

+23 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: RLY-2608+fulvestrant+ribociclib 600 mg for HR+ HER2- locally advanced or metastatic breast cancerExperimental Treatment3 Interventions

Oral dose of RLY-2608 in addition to fulvestrant and ribociclib 600mg as determined during Part 1 Dose Escalation.

Group II: RLY-2608+fulvestrant+ribociclib 400 mg for HR+ HER2- locally advanced or metastatic breast cancerExperimental Treatment3 Interventions

Oral dose of RLY-2608 in addition to fulvestrant and ribociclib 400mg as determined during Part 1 Dose Escalation.

Group III: RLY-2608+fulvestrant+palbociclib 125 mg for HR+ HER2- locally advanced or metastatic breast cancerExperimental Treatment3 Interventions

Oral dose of RLY-2608 in addition to fulvestrant and palbociclib 125mg as determined during Part 1 Dose Escalation.

Group IV: RLY-2608 for patients with unresectable or metastatic solid tumorsExperimental Treatment1 Intervention

Multiple doses of RLY-2608 for oral administration.

Group V: RLY-2608 + fulvestrant combination for HR+ HER2- locally advanced or metastatic breast cancerExperimental Treatment2 Interventions

Oral dose of RLY-2608 in addition to fulvestrant as determined during Part 1 Dose Escalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Palbociclib 125mg

2016

Completed Phase 3

~700

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Relay Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

805 Total Patients Enrolled

1 Trials studying PIK3CA Mutation

265 Patients Enrolled for PIK3CA Mutation

Media Library

Fulvestrant (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05216432 — Phase 1

PIK3CA Mutation Research Study Groups: RLY-2608 for patients with unresectable or metastatic solid tumors, RLY-2608 + fulvestrant combination for HR+ HER2- locally advanced or metastatic breast cancer, RLY-2608+fulvestrant+ribociclib 400 mg for HR+ HER2- locally advanced or metastatic breast cancer, RLY-2608+fulvestrant+ribociclib 600 mg for HR+ HER2- locally advanced or metastatic breast cancer, RLY-2608+fulvestrant+palbociclib 125 mg for HR+ HER2- locally advanced or metastatic breast cancer

PIK3CA Mutation Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT05216432 — Phase 1

Fulvestrant (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05216432 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation for this research project?

"This research necessitates the enrollment of 190 participants that meet pre-defined inclusionary criteria. Individuals can take part in this trial from several areas, including The University of Arizona Cancer Center and UW Carbone Cancer Center."

Answered by AI

What is the stated purpose of this investigation?

"This study's primary objective, which will be assessed over a 24-month period in 4-week cycles until completion, is to ascertain the Maximum Tolerated Dose and Recommended Phase 2 Dose of RLY-2608 when taken solo. Secondary endpoints include alterations in fasting glucose levels with fulvestrant as well as changes in C-peptide concentrations and shifts in PI3Kα signaling once pharmacodynamics are considered."

Answered by AI

Are researchers still accepting applicants for this clinical trial?

"Affirmative. The information found on clinicaltrials.gov shows that this research study, first established December 8th 2021, is currently recruiting participants. Up to 190 people can be enrolled across 11 medical centres."

Answered by AI

What is the prevalence of this trial in urban medical facilities?

"The University of Arizona Cancer Center, UW Carbone Cancer Center, and Memorial Sloan Kettering are the three primary hubs running this clinical trial. Additionally, 11 other medical centres across America have been enlisted to help with data collection."

Answered by AI

What potential hazards should be considered when administering RLY-2608 to patients?

"The safety of RLY-2608 is estimated to be a 1, due to the limited clinical data available which makes it difficult to definitively assess its efficacy or danger."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

2021. "First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216432.

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