Recruiting
Phase 1

LY4337713

Sponsor:

Eli Lilly and Company

Code:

NCT07213791

Conditions

Ovarian Neoplasms

Breast Neoplasms

Pancreatic Intraductal Neoplasms

Colorectal Neoplasms

Esophageal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LY4337713

Study Details

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

Pancreatic Intraductal Neoplasms

Colorectal Neoplasms

Esophageal Neoplasms

Study ID

NCT07213791

Start date

Oct 22, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2033

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 (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.
  • 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 received 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 received at least 2 lines of therapy for metastatic disease.
  • Platinum-resistant or refractory ovarian cancer: Participants must have received 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 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

Enrollment

241 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4337713 (Cohort A1)

Escalating doses of LY4337713 administered intravenously (IV).

experimental: LY4337713 (Cohort A2)

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

experimental: Experimental: LY4337713 (Cohort B)

Tumor specific cohort will receive LY4337713 administered IV.

experimental: Experimental LY4337713 (Cohort C)

Tumor specific cohort will receive LY4337713 administered IV.

experimental: Experimental: LY4337713 (Cohort D)

Tumor specific cohort will receive LY4337713 administered IV.

experimental: LY4337713 (Cohort E)

Tumor specific cohort will receive LY4337713 administered IV.

Interventions

LY4337713

Administered IV.

Primary outcome measure

  • 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) [ Time Frame: Baseline through imaging follow-up, up to 5 years ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Moffitt

Recruiting

Tampa, Florida, United States, 33612

Indiana University (IU) School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

United Theranostics

Recruiting

Glen Burnie, Maryland, United States, 21061

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Barbara Ann Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

BAMF Health Inc.

Recruiting

Grand Rapids, Michigan, United States, 49503

Washington University School of Medicine in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

New York University (NYU) Clinical Cancer Center

Recruiting

New York, New York, United States, 10016

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

Recruiting

New York, New York, United States, 10065

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Texas Oncology - DFW (Sammons CC)

Recruiting

Dallas, Texas, United States, 75246

University of Wisconsin - Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Eli Lilly and Company

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-09-04.