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

NCT07213791 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27513J6K-OX-JSFA
• Study Type: interventional
• Target: 241
• Locations: 4 countries
• Sites: 28

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.

Conditions

Ovarian Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Cholangiocarcinoma; Pancreatic Intraductal Neoplasms

Keywords

Cancer-associated fibroblasts (CAF); Lutetium-177; LuFAP; Lu-177-FAP

Outcome Measures

Primary Outcomes (2)

• 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)

  Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

  Baseline through imaging follow-up, up to 5 years

Secondary Outcomes (8)

• 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

• Phase 1a: Number of Participants with Best Overall Response (BOR)

  Baseline through imaging follow-up, up to 1 year

Study Arms (6)

LY4337713 (Cohort A1)

EXPERIMENTAL

Escalating doses of LY4337713 administered intravenously (IV).

Drug: LY4337713

LY4337713 (Cohort A2)

EXPERIMENTAL

Two or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.

Drug: LY4337713

Experimental: LY4337713 (Cohort B)

EXPERIMENTAL

Tumor specific cohort will receive LY4337713 administered IV.

Drug: LY4337713

Experimental LY4337713 (Cohort C)

EXPERIMENTAL

Tumor specific cohort will receive LY4337713 administered IV.

Drug: LY4337713

Experimental: LY4337713 (Cohort D)

EXPERIMENTAL

Tumor specific cohort will receive LY4337713 administered IV.

Drug: LY4337713

LY4337713 (Cohort E)

EXPERIMENTAL

Tumor specific cohort will receive LY4337713 administered IV.

Drug: LY4337713

Interventions

LY4337713 DRUG

Administered IV.

Experimental LY4337713 (Cohort C); Experimental: LY4337713 (Cohort B); Experimental: LY4337713 (Cohort D); LY4337713 (Cohort A1); LY4337713 (Cohort A2); LY4337713 (Cohort E)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (including ovarian carcinosarcoma)
• 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 received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (28)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

RECRUITING

Moffitt

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Indiana University (IU) School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

United Theranostics

Glen Burnie, Maryland, 21061, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

BAMF Health Inc.

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

New York University (NYU) Clinical Cancer Center

New York, New York, 10016, United States

NOT YET RECRUITING

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

NOT YET RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

NOT YET RECRUITING

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, 75246, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Universitaetsklinikum Essen

Essen, 45147, Germany

NOT YET RECRUITING

Kyoto University Hospital

Kyoto, 606-8507, Japan

NOT YET RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

Amsterdam, 1066 CX, Netherlands

NOT YET RECRUITING

Amsterdam UMC - Locatie VUmc

Amsterdam, 1081 HV, Netherlands

NOT YET RECRUITING

Erasmus MC

GE Rotterdam, 3015, Netherlands

NOT YET RECRUITING

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

NOT YET RECRUITING

Stichting Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

NOT YET RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584CX, Netherlands

NOT YET RECRUITING

Related Links

• Link to Lilly Trials

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Pancreatic Intraductal Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Diseases; Adenocarcinoma; Carcinoma

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 9, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): March 1, 2033
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (6); US (20); JP (1)