A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Brief Title

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Official Title

EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

Brief Summary

      The reason for this study is to see if the study drug LY3484356 alone or in combination with
      other anticancer therapies is safe and effective in participants with advanced or metastatic
      breast cancer or endometrial cancer.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of Participants with Dose Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities

Secondary Outcome

 Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3484356

Condition

Breast Cancer

Intervention

LY3484356

Study Arms / Comparison Groups

 Dose Escalation LY3484356

Description:  LY3484356 given orally.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

December 10, 2019

Completion Date

December 31, 2023

Primary Completion Date

June 29, 2020

Eligibility Criteria

        Inclusion Criteria:

        All study parts:

          -  Participants must be willing to provide adequate archival tissue sample

          -  Participants must be willing to use highly effective birth control

          -  Participants must have adequate organ function

          -  Participants must be able to swallow capsules

        Dose escalation- Participants must have one of the following:

          -  Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable
             or metastatic disease who have had the following:

          -  Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic
             setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.

          -  Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine
             therapy in the advanced/metastatic setting, and must have received a prior CDK4/6
             inhibitor

          -  Cohort E4: No prior everolimus.

          -  Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic
             α (PIK3Cα) mutation as determined by local testing.

          -  Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer
             with evidence of locally advanced unresectable or metastatic disease who have had at
             least 2 HER2-directed therapies in any setting.

          -  Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no
             prior fulvestrant or aromatase inhibitor therapy.

          -  Part E: ER+ and HER2+ breast cancer with evidence of locally advanced, unresectable,
             or metastatic disease.

          -  Part E: Participants must have received induction taxane chemotherapy combined with
             trastuzumab + pertuzumab as first-line treatment for advanced/metastatic disease and
             must not have progressed on this regimen.

          -  Part E: Participants must not have received more than 1 HER2-directed regimen or any
             endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy.

        Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of
        clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting
        or at least 6 months in the advanced/metastatic setting or have untreated de novo
        metastatic breast cancer

        Exclusion Criteria:

          -  Participants must not have certain infections such as hepatitis or tuberculosis or HIV
             that are not well controlled

          -  Participants must not have another serious medical condition

          -  Participants must not have cancer of the central nervous system that is unstable

          -  Participants must not be pregnant or breastfeeding

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), 1-317-615-4559, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT04188548

Organization ID

Secondary IDs

J2J-MC-JZLA

Responsible Party

Sponsor

Study Sponsor

Eli Lilly and Company

Study Sponsor

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company

Verification Date

September 2022