Samuraciclib + Elacestrant for Advanced Breast Cancer

(SUMIT-ELA Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Carrick Therapeutics Limited

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.

Eligibility Criteria

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.

Inclusion Criteria

Expected life expectancy of >12 weeks in the judgement of the treating investigator.

I know my TP53 and ESR1 mutation status.

I started treatment with an LHRH agonist at least 4 weeks ago.

Exclusion Criteria

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

I haven't had any cancer except for certain skin cancers or cervical pre-cancer in the last 3 years.

My condition is inflammatory breast cancer.

Participant Groups

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.

Group I: Cohort 4 Expansion Experimental Treatment 2 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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).

Elacestrant is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Orserdu for:

• ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

🇪🇺 Approved in European Union as Orserdu for:

• ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus Seattle, WA

Site 42 - Dana-Farber Cancer Institute, EDDC Boston, MA

Site 35 - Cleveland Clinic, Taussig Cancer Institute Cleveland, OH

Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University Chicago, IL

More Trial Locations

Who Is Running the Clinical Trial?

Carrick Therapeutics Limited Lead Sponsor

Berlin-Chemie AG Menarini Group Industry Sponsor

References