A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • LY4337713

    Drug

    Administered IV.

Treatment groups

241 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: LY4337713 (Cohort A1)Experimental treatment 1 intervention
Group B: LY4337713 (Cohort A2)Experimental treatment 1 intervention
Group C: Experimental: LY4337713 (Cohort B)Experimental treatment 1 intervention
Group D: Experimental LY4337713 (Cohort C)Experimental treatment 1 intervention
Group E: Experimental: LY4337713 (Cohort D)Experimental treatment 1 intervention
Group F: LY4337713 (Cohort E)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities

Time frame
Cycle 1 (28 days)
2

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 outcomes

1

Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs

Time frame
Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)
2

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)
3

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)
4

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

Other outcomes

Sponsors and contacts

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