Your session is about to expire
← Back to Search
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
Must not have
Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%
Familial history of prolonged QT syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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).
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 belowSelect...
I have been treated for advanced breast cancer with specific drugs.
Select...
I have breast cancer that cannot be surgically removed or cured, and it is hormone receptor positive and HER2 negative.
Select...
I am fully active or can carry out light work.
Select...
My condition hasn't improved with standard treatments, or I can't tolerate them.
Select...
My cancer has a PIK3CA mutation.
Select...
My cancer is confirmed to be advanced and cannot be removed by surgery.
Select...
My cancer is advanced, cannot be surgically removed, and has a PIK3CA mutation.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes and take medication, or my blood sugar and HbA1c levels are high.
Select...
My family has a history of prolonged QT syndrome.
Select...
I have a history of abnormal heart rhythms.
Select...
I have a serious heart condition that is not under control.
Select...
My brain tumor is getting worse and affecting my nervous system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
~3890
Palbociclib 125mg
2016
Completed Phase 4
~720
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped a PI3Kα inhibitor treatment due to side effects, not because my disease got worse.I can provide a sample of my tumor or am willing to have a biopsy for testing.I have diabetes and take medication, or my blood sugar and HbA1c levels are high.I have breast cancer that cannot be surgically removed or cured, and it is hormone receptor positive and HER2 negative.I have been treated for advanced breast cancer with specific drugs.I will provide a sample of my tumor for PIK3CA mutation testing before starting the study drug.My family has a history of prolonged QT syndrome.I have a history of abnormal heart rhythms.You have a disease that can be measured and evaluated using a specific medical guideline.I am fully active or can carry out light work.My condition hasn't improved with standard treatments, or I can't tolerate them.I have had pneumonitis or lung disease in the past.I have a serious heart condition that is not under control.My cancer has a PIK3CA mutation that needs sponsor approval before I can join.You have a disease that can be measured using specific guidelines.You have had a bad reaction to PI3K inhibitors in the past.I have not taken PI3Kα, AKT, or mTOR inhibitors before.My cancer has a PIK3CA mutation.My cancer is confirmed to be advanced and cannot be removed by surgery.My cancer is advanced, cannot be surgically removed, and has a PIK3CA mutation.You have had a bad allergic reaction to fulvestrant, palbociclib, or ribociclib.Your heart's electrical activity (QTcF) is too long.Your heart's electrical activity, called the QT interval, is longer than 480 milliseconds.My brain tumor is getting worse and affecting my nervous system.
Research Study Groups:
This trial has the following groups:- Group 1: RLY-2608 for patients with unresectable or metastatic solid tumors
- Group 2: RLY-2608 + fulvestrant combination for HR+ HER2- locally advanced or metastatic breast cancer
- Group 3: RLY-2608+fulvestrant+ribociclib 400 mg for HR+ HER2- locally advanced or metastatic breast cancer
- Group 4: RLY-2608+fulvestrant+ribociclib 600 mg for HR+ HER2- locally advanced or metastatic breast cancer
- Group 5: RLY-2608+fulvestrant+palbociclib 125 mg for HR+ HER2- locally advanced or metastatic breast cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger