What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those targeting the PI3K pathway like RLY-5836, often include side effects such as hyperglycemia, rash, diarrhea, and liver function abnormalities. Other treatments, such as chemotherapy, can cause nausea, fatigue, hair loss, and increased risk of infection. Hormonal therapies may lead to hot flashes, joint pain, and bone thinning. Targeted therapies can also result in specific side effects depending on the drug used, such as cardiotoxicity with HER2 inhibitors.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that target the PI3K pathway. One notable example is alpelisib, an alpha-specific PI3K inhibitor, which is approved for use in combination with fulvestrant for hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. This approval was based on clinical trials demonstrating its efficacy in this specific patient population. Other related drugs include everolimus, an mTOR inhibitor, which is used in combination with exemestane for hormone receptor-positive, HER2-negative advanced breast cancer after failure of treatment with letrozole or anastrozole.

What other types of research exist?

Promising alternatives to RLY-5836 for breast cancer patients include: 1) Alpelisib (PI3K inhibitor) in combination with fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. 2) Everolimus (mTOR inhibitor) combined with exemestane or fulvestrant for HR-positive, HER2-negative advanced breast cancer. 3) CDK4/6 inhibitors like Palbociclib, Ribociclib, and Abemaciclib in combination with endocrine therapy for HR-positive, HER2-negative advanced breast cancer. 4) Immunotherapy agents such as Pembrolizumab for PD-L1 positive triple-negative breast cancer.

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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

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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RLY-5836 in patients with advanced cancers that have a PIK3CA mutation. The drug aims to block this mutation to slow down tumor growth. The study will determine how safe and effective the drug is.

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.

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).

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

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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 is confirmed and cannot be removed by surgery.

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

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My cancer has a PIK3CA mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes and take medication, or my blood sugar and HbA1c levels are high.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3520

Palbociclib

2017

Completed Phase 3

~3880

Ribociclib

2018

Completed Phase 3

~2420

Abemaciclib

2019

Completed Phase 2

~1890

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast cancer include endocrine therapy, chemotherapy, HER2-targeted therapies, and PI3K pathway inhibitors. Endocrine therapy works by blocking hormones that fuel cancer growth, while chemotherapy kills rapidly dividing cancer cells. HER2-targeted therapies, like trastuzumab, inhibit the HER2 protein that promotes cancer cell growth. PI3K pathway inhibitors, such as those being studied in the RLY-5836 trial, target the PI3K signaling pathway, which is often mutated in breast cancer, leading to uncontrolled cell growth. Understanding these mechanisms is crucial for breast cancer patients as it helps tailor treatments to their specific cancer type, potentially improving outcomes and minimizing side effects.

[Trastuzumab (Herceptin) and breast cancer: mechanisms of resistance].