RLY-5836 for Advanced Breast Cancer

Recruiting at 6 trial locations

Overseen By Relay Therapeutics Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Relay Therapeutics, Inc.

Must be taking: GnRH agonists

Must not be taking: PI3Kα inhibitors

Disqualifiers: Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

265 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have diabetes requiring medication, you may not be eligible to participate.

What data supports the effectiveness of the drug RLY-5836 for advanced breast cancer?

While there is no direct data on RLY-5836, similar treatments like fulvestrant have shown effectiveness in advanced breast cancer, especially after other therapies fail. Fulvestrant works by blocking estrogen receptors, which can help slow the growth of certain breast cancers. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have HR+ and HER2- advanced breast cancer and cannot undergo surgery to cure it.

I am fully active or can carry out light work.

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

Exclusion Criteria

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

I have previously been treated with PI3Kα inhibitors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive RLY-5836 to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)

8-12 weeks

Dose Expansion

Participants receive RLY-5836 in combination with other therapies to evaluate safety, tolerability, and preliminary anti-tumor activity

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• RLY-5836

Trial Overview 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).

Participant Groups

Group I: RLY-5836 Single Agent Arm Experimental Treatment 1 Intervention

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

Group II: RLY-5836 + Ribociclib + Fulvestrant Arm Experimental Treatment 3 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 Arm Experimental Treatment 3 Interventions

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

Group IV: RLY-5836 + Fulvestrant Arm Experimental Treatment 2 Interventions

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

Group V: RLY-5836 + Abemaciclib + Fulvestrant Arm Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Relay Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,900+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

ER and PI3K Pathway Activity in Primary ER Positive Breast Cancer Is Associated with Progression-Free Survival of Metastatic Patients under First-Line Tamoxifen. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fulvestrant ('Faslodex'): current and future role in breast cancer management. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Network Meta-Analysis Comparing Overall Survival for Fulvestrant 500 mg Versus Alternative Therapies for Treatment of Postmenopausal, Estrogen Receptor-Positive Advanced Breast Cancer Following Failure on Prior Endocrine Therapy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of fulvestrant in clinical practice: use of an electronic data registry. [2018]

5. Scotland pubmed.ncbi.nlm.nih.gov

Treatment strategies for advanced hormone receptor-positive and human epidermal growth factor 2-negative breast cancer: the role of treatment order. [2016]