About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
Adenocarcinoma of the pancreas
Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer
HER2-positive breast cancer
Disqualifiers
Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
Have significant cardiovascular disease
Have prolongation of the corrected QTcF >470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)
Have evidence of ongoing and untreated urinary tract obstruction
Trial design
Sequential
Treatments tested in this trial
LY4337713
DrugAdministered IV.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
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)
Secondary outcomes
Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs
Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713
Phase 1a: PK: Area Under the Concentration Time Curve (AUC) of LY4337713
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.
Sponsors and contacts
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