A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)
Summary
This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.
Arms & interventions
- DrugLY4337713
Administered IV.
Outcome measures
Primary
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
Time frame: Cycle 1 (28 days)
Phase 1b: Objective 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 through imaging follow-up, up to 5 years
Secondary
Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs
Time frame: Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)
Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
Phase 1a: PK: Area Under the Concentration Time Curve (AUC) of LY4337713
Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
Phase 1a: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through imaging follow-up, up to 1 year
Phase 1a: Number of Participants with Best Overall Response (BOR)
Time frame: Baseline through imaging follow-up, up to 1 year
Phase 1a and 1b: Duration of Response (DOR)
Time frame: Baseline through imaging follow-up, up to 5 years
Phase 1a and 1b: Time to Response (TTR)
Time frame: Baseline through imaging follow-up, up to 1 year
Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR)
Time frame: Baseline through imaging follow-up, up to 1 year
Eligibility criteria
Study locations (20)
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Stanford University Medical Center
Stanford, California, 94305
Biogenix Molecular, LLC
Miami, Florida, 33165
Moffitt
Tampa, Florida, 33612
Indiana University (IU) School of Medicine
Indianapolis, Indiana, 46202
United Theranostics
Glen Burnie, Maryland, 21061
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
BAMF Health Inc.
Grand Rapids, Michigan, 49503
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
New York University (NYU) Clinical Cancer Center
New York, New York, 10016
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Duke University Medical Center
Durham, North Carolina, 27710
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Texas Oncology - DFW (Sammons CC)
Dallas, Texas, 75246
Baylor College of Medicine
Houston, Texas, 77030
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53792