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Selective Estrogen Receptor Downregulator (SERD)

Samuraciclib + Elacestrant for Advanced Breast Cancer (SUMIT-ELA Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Carrick Therapeutics Limited

Eligibility Criteria Checklist

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

Must have

Known TP53 and ESR1 mutation status.

Received prior AI in combination with a CDK4/6i as the last therapy.

Must not have

Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.

Inflammatory breast cancer.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new med combo to treat advanced breast cancer. Safety & effectiveness will be checked.

Who is the study for?

This trial is for adults with HR+/HER2-negative advanced or metastatic breast cancer who've seen their disease progress after recent therapy. They must have had prior treatment with an AI and a CDK4/6 inhibitor, know their TP53 and ESR1 mutation status, and meet certain health criteria like good organ function and performance status.

What is being tested?

The study tests the safety and effectiveness of combining two drugs, Samuraciclib and Elacestrant Dihydrochloride, in treating advanced breast cancer. It's an international Phase 1b/2 trial where all participants will receive both medications to see how well they work together.

What are the potential side effects?

While specific side effects are not listed here, common ones for cancer treatments may include nausea, fatigue, risk of infection due to low blood cell counts, liver issues, hormonal changes (especially relevant for premenopausal women), as well as potential heart or kidney problems.

Eligibility Criteria

Inclusion Criteria

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

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I know my TP53 and ESR1 mutation status.

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My last cancer treatment was with AI and a CDK4/6 inhibitor.

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My breast cancer is ER-positive and HER2-negative, and it has spread.

Exclusion Criteria

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

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I have had cancer spread to my brain or its coverings.

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My condition is inflammatory breast cancer.

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My liver, kidneys, and bone marrow are not working well.

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I have had more than one hormone therapy for my advanced cancer.

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I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of any study intervention (cycle 1 day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of any study intervention (cycle 1 day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of any study intervention (cycle 1 day 1) to ≥ 24 weeks or until disease progression or death to any cause (assessed up to week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1b (Dose-finding)

Phase 2 (Expansion)

Secondary study objectives

Best percent change in tumor size.

Clinical Benefit Response (CBR)

Duration of Response (DOR)

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4 ExpansionExperimental Treatment2 Interventions

Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Group II: Cohort 3Experimental Treatment2 Interventions

Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Group III: Cohort 2Experimental Treatment2 Interventions

Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).

Group IV: Cohort 1Experimental Treatment2 Interventions

Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).

0 / 8Eligibility criteria met