LY3484356
DrugAdministered orally
Other names: Imlunestrant
NCT Number: NCT04188548
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All study parts:
Dose escalation- Participants must have one of the following:
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
Administered orally
Other names: Imlunestrant
Administered orally
Other names: LY2835219
Administered orally
Administered orally
Administered intravenously
Anastrozole or Exemestane or Letrozole administered orally (physician choice)
Administered intravenously
Time frame: Baseline through Cycle 1 (21/28 Day Cycle)
Number of Participants with DLTs and DLT-Equivalent Toxicities
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: AUC of LY3484356
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: Cmax of LY3484356
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: AUC of LY3484356 in Combination with Other Anticancer Therapies
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 2 Day 1 (21/28 Day Cycles)
PK: Cmax of LY3484356 in Combination with Other Anticancer Therapies
Time frame: Baseline through Disease Progression or Death (Estimated up to 28 Months)
ORR: Percentage of Participants with Confirmed CR or PR as per RECIST v1.1
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 28 Months)
DoR: Time From the Date of First Evidence of CR, PR (per RESIST v1.1) to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
Time frame: Baseline through Measured Progressive Disease (Estimated up to 28 Months)
DCR: Percentage of Participants with a BOR of CR, PR, and SD as per RECIST v1.1
Time frame: Baseline through Measured Progressive Disease (Estimated up to 28 Months)
CBR: Percentage of Participants with a BOR of CR or PR, or SD lasting ≥24 weeks as per RECIST v1.1
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 28 Months)
PFS: Time From Baseline to the Date of Objective Progression or Death Due to Any Cause, Whichever is Earlier
Eli Lilly and Company
Industry
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
Acronym: EMBER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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