← Back to Search

PI3K Inhibitor

RLY-5836 for Advanced Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Relay Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Patient has ECOG performance status of 0-1

Disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately every week in cycle 1 (4-week cycle), every 2 weeks in cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months

Awards & highlights

Study Summary

This trial tests a new medicine for advanced solid tumors in those with a PIK3CA mutation. It aims to determine the safety, effectiveness, and how the body interacts with it.

Who is the study for?

This trial is for adults with advanced breast cancer or other solid tumors that have a PIK3CA mutation. Participants should be in good physical condition (ECOG 0-1), and women must be postmenopausal, treated with GnRH agonists, or otherwise not of childbearing potential. They should have tried standard treatments without success or cannot tolerate them.Check my eligibility

What is being tested?

RLY-5836 is being tested to find the safest and most effective dose for treating advanced solid tumors with a PIK3CA mutation. The study has two parts: first, finding the maximum tolerated dose (Part 1) and then expanding the trial to more patients at this dose (Part 2).See study design

What are the potential side effects?

Possible side effects include typical reactions from cancer drugs like nausea, fatigue, blood sugar changes which could affect diabetics, allergic reactions if previously experienced on similar medications, and others as yet unknown due to its first-in-human status.

Eligibility Criteria

Inclusion Criteria

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

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 is confirmed and cannot be removed by surgery.

Select...

I have been treated with hormone therapy for advanced breast cancer.

Select...

My cancer has a PIK3CA mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately every week in cycle 1 (4-week cycle), every 2 weeks in cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately every week in cycle 1 (4-week cycle), every 2 weeks in cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately every week in cycle 1 (4-week cycle), every 2 weeks in cycle 2 (4-week cycle), and every cycle through end of treatment (4-week cycles), approximately 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

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836

Number of participants with adverse events (AEs)

Number of participants with any dose-limiting toxicity (DLT)

+1 more

Secondary outcome measures

Changes in circulating markers of glucose metabolism: changes in circulating C-peptide

Changes in circulating markers of glucose metabolism: changes in circulating glucose

Changes in circulating markers of glucose metabolism: changes in circulating glycosylated hemoglobin [HbA1c]

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: RLY-5836 Single Agent ArmExperimental Treatment1 Intervention

RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors

Group II: RLY-5836 + Ribociclib + Fulvestrant ArmExperimental Treatment3 Interventions

RLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Group III: RLY-5836 + Palbociclib + Fulvestrant ArmExperimental Treatment3 Interventions

RLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Group IV: RLY-5836 + Fulvestrant ArmExperimental Treatment2 Interventions

RLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Group V: RLY-5836 + Abemaciclib + Fulvestrant ArmExperimental Treatment3 Interventions

RLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Palbociclib

2017

Completed Phase 3

~3760

Ribociclib

2018

Completed Phase 3

~2330

Abemaciclib

2019

Completed Phase 2

~1710

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Relay Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

940 Total Patients Enrolled

1 Trials studying Breast Cancer

400 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Has the RLY-5836 Single Agent Arm obtained FDA approval?

"RLY-5836 Single Agent Arm has not been extensively tested, so it was given a rating of 1 on the safety scale. This is because Phase 1 trials only provide limited evidence regarding treatment efficacy and patient protection."

Answered by AI

Are any fresh participants being welcomed into the trial currently?

"Indeed, according to the information provided on clinicaltrials.gov this trial is actively looking for participants since its initiation date of March 29th 2023 and its most recent update on April 10th 2023. 220 subjects across 1 location are needed for successful completion of the study."

Answered by AI

What is the sample size of this research project?

"Affirmative, the info on clinicaltrials.gov confirms that this medical trial is actively enrolling participants. The original posting date was March 29th 2023 and has most recently been edited April 10th of the same year. There are 220 prospective patients needed from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

2023. "First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05759949.