Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07213791

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

Led by Eli Lilly and Company · Updated on 2026-05-14

241

Participants Needed

29

Research Sites

383 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
  • Must have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, hormone receptor-positive HER2-negative breast cancer, HER2-positive breast cancer, triple negative breast cancer, platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma), gastric cancer (adenocarcinoma), colorectal cancer, esophageal cancer (squamous cell carcinoma or adenocarcinoma), or cholangiocarcinoma
  • Must have received prior treatments as follows: for Phase 1a, pancreatic adenocarcinoma patients must have had 1 to 2 prior regimens; HR-positive HER2-negative breast cancer patients up to 5 prior lines including a CDK4/6 inhibitor; HER2-positive breast cancer patients at least 2 lines of HER2-targeted therapy including 1 antibody-drug conjugate if available; triple negative breast cancer patients at least 2 lines for metastatic disease; platinum-resistant or refractory ovarian cancer patients at least 1 platinum-based therapy; other solid tumor patients at least 1 prior systemic therapy including immunotherapy or VEGF inhibitors
  • For Phase 1b, participants must have advanced or metastatic solid tumors and at least 1 prior line of therapy
  • Must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
  • Measured creatinine clearance of at least 60 milliliters per minute
Not Eligible

You will not qualify if you...

  • Known active central nervous system metastases or carcinomatous meningitis
  • Significant cardiovascular disease
  • Prolonged corrected QTcF greater than 470 milliseconds during screening
  • Evidence of ongoing and untreated urinary tract obstruction
  • Previous hemi- or total-body radiation
  • Previous adoptive T-cell therapy such as CAR-T or TCR therapy
  • Unable to lie flat or tolerate imaging procedures including SPECT, PET, CT, or MRI

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 29 locations

1

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

2

Stanford University Medical Center

Stanford, California, United States, 94305

Actively Recruiting

3

Biogenix Molecular, LLC

Miami, Florida, United States, 33165

Actively Recruiting

4

Moffitt

Tampa, Florida, United States, 33612

Not Yet Recruiting

5

Indiana University (IU) School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

6

United Theranostics

Glen Burnie, Maryland, United States, 21061

Actively Recruiting

7

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

8

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Not Yet Recruiting

9

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Not Yet Recruiting

10

BAMF Health Inc.

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

11

Mayo Clinic - Rochester

Rochester, Minnesota, United States, 55905

Not Yet Recruiting

12

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States, 63110

Not Yet Recruiting

13

New York University (NYU) Clinical Cancer Center

New York, New York, United States, 10016

Not Yet Recruiting

14

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

New York, New York, United States, 10065

Not Yet Recruiting

15

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

16

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

17

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Not Yet Recruiting

18

Texas Oncology - DFW (Sammons CC)

Dallas, Texas, United States, 75246

Not Yet Recruiting

19

Baylor College of Medicine

Houston, Texas, United States, 77030

Not Yet Recruiting

20

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Actively Recruiting

21

Universitaetsklinikum Essen

Essen, Germany, 45147

Not Yet Recruiting

22

National Cancer Center Hospital East

Chiba, Japan, 277-8577

Not Yet Recruiting

23

Kyoto University Hospital

Kyoto, Japan, 606-8507

Not Yet Recruiting

24

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

Amsterdam, Netherlands, 1066 CX

Not Yet Recruiting

25

Amsterdam UMC - Locatie VUmc

Amsterdam, Netherlands, 1081 HV

Not Yet Recruiting

26

Erasmus MC

GE Rotterdam, Netherlands, 3015

Not Yet Recruiting

27

Maastricht University Medical Center

Maastricht, Netherlands, 6229 HX

Not Yet Recruiting

28

Stichting Radboud Universitair Medisch Centrum

Nijmegen, Netherlands, 6525 GA

Not Yet Recruiting

29

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands, 3584CX

Not Yet Recruiting

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Research Team

T

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

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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