Selective ER Degrader
Imlunestrant
Phase
1
Not Enrolling
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*
Related Resources:
Key Inclusion Criteria
- All study parts:
- Willing to provide adequate archival tissue sample
- Willing to use highly effective birth control
- Adequate organ function
- Able to swallow capsules
- Participants must have one of the following (dose escalation):
- Parts A and B: Estrogen-receptor-positive (ER+), HER2-negative breast cancer with evidence of locally advanced, unresectable or metastatic disease and have had the following:
- Part A: May have had up to one prior regimen of any kind in the advanced/metastatic setting and no prior cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy
- Part B: May have had up to two prior regimens; no more than one 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+, HER2-positive 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-positive 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 one HER2-directed regimen or any endocrine therapy for advanced disease or any prior CDK4/6 inhibitor therapy
- Participants with ER+, HER2-negative 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
Key Exclusion Criteria
- Uncontrolled infections such as hepatitis, tuberculosis, or HIV
- Another serious medical condition
- Unstable cancer of the central nervous system
- Pregnant or breastfeeding
*
This clinical trial is being conducted globally.
†
LY3484356 is administered PO QD.
‡
Abemaciclib is administered PO BID.
§
Aromatase inhibitor (AI) is administered PO.
‖
Everolimus is administered PO QD.
¶
Alpelisib is administered PO QD.
#
Trastuzumab is administered intravenously (IV) Q21D.
**
Pertuzumab is administered IV Q21D.
