The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
IV infusion
IV infusion
IV infusion
IV infusion
Stanford Medicine Cancer Center
Stanford, California, United States
RECRUITINGFlorida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, United States
RECRUITINGFlorida Cancer Specialists - Sarasota
Sarasota, Florida, United States
RECRUITINGThe University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408
Time frame: 1 Cycle (21 days)
Phase 1b-Overall Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of LY4175408 (total antibody, conjugated antibody, free payload)
Time frame: First 4 cycles (84 days)
Phase 1a and 1b-PK: Area under the Concentration versus Time Curve (AUC) of LY4175408 (total antibody, conjugated antibody, free payload)
Time frame: First 4 cycles (84 days)
Phase 1a-ORR: Percentage of Participants with Best Response of CR or PR
Per investigator assessed RECIST 1.1
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Time to Response (TTR)
Per investigator assessed RECIST 1.1
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Progression-free Survival (PFS)
Per investigator assessed RECIST 1.1
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Disease Control Rate (DCR)
Per investigator assessed RECIST 1.1
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Duration of Response (DOR)
Per investigator assessed RECIST 1.1
Time frame: Baseline up to approximately 4 years
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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Community Health Network
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGJohn Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 17 more locations