ECI830 + Ribociclib + Fulvestrant for Breast Cancer

Recruiting at 7 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Ribociclib, Fulvestrant

Must not be taking: CDK2 inhibitors

Disqualifiers: Heart disease, CNS metastases, others

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

Compensation: Varies

Number of Visits: Unknown

280 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.

Eligibility Criteria

This trial is for adults with advanced hormone receptor-positive, HER2-negative breast cancer who've seen their disease progress after treatment with aromatase inhibitors or tamoxifen and a CDK4/6 inhibitor. They should have measurable disease or at least one assessable lytic bone lesion if no measurable disease is present. Participants can't have had more than two lines of endocrine therapy or three prior therapies for metastatic disease.

Inclusion Criteria

My breast cancer is HR+/HER2- and has worsened despite specific hormone treatments.

My cancer can be measured using standard criteria.

My breast cancer is HR+/HER2- and has worsened despite hormone therapy and other treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.

28 days

Multiple visits for dose escalation and monitoring

Phase II Treatment

Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with HR+/HER2- advanced breast cancer.

6 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• ECI830
• Fulvestrant
• Ribociclib

Trial Overview The study has two parts: Phase I tests the safety and best dose of ECI830 alone and combined with ribociclib and fulvestrant. Phase II evaluates how well ECI830 works in combination with these drugs to treat HR+/HER2- advanced breast cancer by measuring its effect on tumor size.

Participant Groups

Group I: Ribociclib in combination with fulvestrant (Arm C) Experimental Treatment 2 Interventions

Phase II

Group II: ECI830 in combination with ribociclib and fulvestrant (Arm F) Experimental Treatment 3 Interventions

Phase II

Group III: ECI830 in combination with ribociclib and fulvestrant (Arm E) Experimental Treatment 3 Interventions

Phase II

Group IV: ECI830 in combination with fulvestrant (Arm D) Experimental Treatment 2 Interventions

Phase II

Group V: ECI830 Single Agent (Arm A) Experimental Treatment 1 Intervention

Phase I

Group VI: Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B) Experimental Treatment 3 Interventions

Phase I

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD