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

Not Applicable

Not yet recruiting

• Conditions: Ovarian Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Breast Neoplasms; Pancreatic Intraductal Neoplasms; Cholangiocarcinoma
• Interventions: Drug: LY4337713

• Registration Number: NCT07213791
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2028-07
• Study Completion: 2033-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

• Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment

• Must have histologically or cytologically confirmed diagnosis of one of the following:

  • Adenocarcinoma of the pancreas

  • Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer

  • HER2-positive breast cancer

  • Triple negative breast cancer (TNBC)

  • Platinum-resistant or refractory ovarian cancer

  • Other solid tumors

    • Gastric cancer (adenocarcinoma)
    • Colorectal cancer (CRC)
    • Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
    • Cholangiocarcinoma

• Must have received prior treatments as indicated below:

  • Phase 1a

    • Adenocarcinoma of the pancreas: Participants must have progressed after at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.
    • HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4/6 inhibitor.
    • HER2-positive breast cancer: Participants must have progressed on at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).
    • TNBC: Participants must have progressed on at least 2 lines of therapy for metastatic disease.
    • Platinum-resistant or refractory ovarian cancer: Participants must have progressed on or after at least 1 platinum-based therapy.
    • Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.

  • Phase 1b:

    • Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.

• Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.

• Measured creatinine clearance ≥60 milliliters per minute (mL/min)

Exclusion Criteria

• Have known active central nervous system (CNS) metastases or carcinomatous meningitis.
• Have history of Grade 4 myelosuppression lasting greater than (>)7 days, or Grade 3 myelosuppression requiring more than 6 weeks recovery.
• 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
• Had previous hemi- or total-body radiation.
• Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T therapy, T-cell receptor [TCR] therapy, etc.)
• Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY4337713 (Cohort A1)	LY4337713	Escalating doses of LY4337713 administered intravenously (IV).
LY4337713 (Cohort A2)	LY4337713	Two or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.
Experimental: LY4337713 (Cohort B)	LY4337713	Tumor specific cohort will receive LY4337713 administered IV.
Experimental LY4337713 (Cohort C)	LY4337713	Tumor specific cohort will receive LY4337713 administered IV.
Experimental: LY4337713 (Cohort D)	LY4337713	Tumor specific cohort will receive LY4337713 administered IV.
LY4337713 (Cohort E)	LY4337713	Tumor specific cohort will receive LY4337713 administered IV.

Primary Outcome Measures

Name	Time	Method
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities	Cycle 1 (28 days)
Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)	Baseline through imaging follow-up, up to 5 years	Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Secondary Outcome Measures

Name	Time	Method
Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs	Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)
Phase 1a: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713	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	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)	Baseline through imaging follow-up, up to 1 year	Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Phase 1a: Number of Participants with Best Overall Response (BOR)	Baseline through imaging follow-up, up to 1 year	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.
Phase 1a and 1b: Duration of Response (DOR)	Baseline through imaging follow-up, up to 5 years	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.
Phase 1a and 1b: Time to Response (TTR)	Baseline through imaging follow-up, up to 1 year	Time from first dose date to the date of first documented response of CR or PR
Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR)	Baseline through imaging follow-up, up to 1 year	Percentage participants who achieved a BOR of CR, PR, or stable disease (SD), per RECIST v1.1

Trial Locations

Locations (16)

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Biogenix Molecular, LLC; 🇺🇸 Miami, Florida, United States

Indiana University (IU) School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

United Theranostics; 🇺🇸 Glen Burnie, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

BAMF Health Inc.; 🇺🇸 Grand Rapids, Michigan, United States

Washington University School of Medicine in St. Louis; 🇺🇸 St Louis, Missouri, United States

Scroll for more (6 remaining)