The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
Administered by IV infusion
City of Hope
Duarte, California, United States
University of Colorado Denver - School of Medicine - Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Phase 1 - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199
Time frame: Cycle 1 Day 1 through Cycle 2 Day 8 (35 days)
Phase 1 - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199
Time frame: Baseline up to approximately 91 weeks
Phase 1- PK: Maximum drug Concentration (Cmax) of LY4152199
Time frame: Baseline up to approximately 91 weeks
Phase 1 - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response (BOR) of Partial Response (PR) or Better.
Assessed by the Investigator per disease-specific response criteria as appropriate to disease indication.
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1 - Duration of Response (DOR)
Time between the date of first documented response (PR or better) to the date of first disease progression or death due to any cause, whichever occurs first
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1- Time to Response (TTR)
Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (PR or better)
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Phase 1 - Progression Free Survival (PFS)
Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first
Time frame: Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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University of Iowa
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
...and 40 more locations