A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Summary
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.
Arms & interventions
- DrugLY4175408
IV infusion
- DrugPembrolizumab
IV infusion
- DrugCarboplatin
IV infusion
- DrugCisplatin
IV infusion
Outcome measures
Primary
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
Secondary
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
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Time to Response (TTR)
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Progression-free Survival (PFS)
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Disease Control Rate (DCR)
Time frame: Baseline up to approximately 4 years
Phase 1a and 1b-Duration of Response (DOR)
Time frame: Baseline up to approximately 4 years
Eligibility criteria
Study locations (15)
Stanford Medicine Cancer Center
Stanford, California, 94305
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute
Orlando, Florida, 32827
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34236
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, 60637
Community Health Network
Indianapolis, Indiana, 46250
Massachusetts General Hospital
Boston, Massachusetts, 02114
Washington University
St Louis, Missouri, 63110
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, 07601
Columbia University
New York, New York, 10032
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
The Ohio State University (OSU) Wexner Medical Center
Columbus, Ohio, 43210
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
START Mountain Region
West Valley City, Utah, 84119
NEXT Virginia
Fairfax, Virginia, 22031