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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
Administered IV.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
RECRUITINGStanford University Medical Center
Stanford, California, United States
NOT_YET_RECRUITINGBiogenix Molecular, LLC
Miami, Florida, United States
RECRUITINGIndiana University (IU) School of Medicine
Indianapolis, Indiana, United States
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
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)
Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Baseline through imaging follow-up, up to 1 year
Phase 1a: Number of Participants with Best Overall Response (BOR)
Best response recorded from the start of study treatment until the earliest of objective disease progression or start of new anticancer therapy, per RECIST v1.1.
Time frame: Baseline through imaging follow-up, up to 1 year
Phase 1a and 1b: Duration of Response (DOR)
Time between the date of first documented response of CR or PR to the date of first disease progression, as assessed by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Baseline through imaging follow-up, up to 5 years
Phase 1a and 1b: Time to Response (TTR)
Time from first dose date to the date of first documented response of CR or PR
Time frame: Baseline through imaging follow-up, up to 1 year
Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR)
Percentage participants who achieved a BOR of CR, PR, or stable disease (SD), per RECIST v1.1
Time frame: Baseline through imaging follow-up, up to 1 year
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
United Theranostics
Glen Burnie, Maryland, United States
NOT_YET_RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGBarbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
NOT_YET_RECRUITINGBAMF Health Inc.
Grand Rapids, Michigan, United States
RECRUITINGMayo Clinic - Rochester
Rochester, Minnesota, United States
NOT_YET_RECRUITING...and 15 more locations