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New radioactive drug targets FAP-Positive tumors in early trial

NCT ID NCT07213791

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This early-phase study tests a new radioactive drug, LY4337713, in people with advanced cancers that have high levels of a protein called FAP. The cancers include certain types of ovarian, breast, pancreatic, colorectal, esophageal, stomach, and bile duct cancers. The study aims to find safe doses and see if the drug can shrink tumors. About 241 participants will be followed for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4337713 (a radioligand therapy given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for several hard-to-treat cancers that have a specific protein called FAP.
What could go wrong
This is a very early Phase 1 trial, so the main goals are safety and dosing—not yet proving it works. The drug may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 241 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

breast neoplasm cholangiocarcinoma colorectal cancer colorectal neoplasm esophageal adenocarcinoma esophageal cancer Esophageal Neoplasms esophageal squamous cell carcinoma gastric adenocarcinoma gastric neoplasm HER2 positive breast carcinoma hormone receptor-positive breast cancer neoplasm of esophagus ovarian cancer ovarian carcinoma ovarian carcinosarcoma ovarian neoplasm pancreatic adenocarcinoma Pancreatic Intraductal Neoplasms pancreatic intraductal papillary-mucinous neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Cholangiocarcinoma Colorectal neoplasms Esophageal neoplasms Ovarian neoplasms Pancreatic intraductal neoplasms Stomach neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC - Locatie VUmc

    NOT_YET_RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • BAMF Health Inc.

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Barbara Ann Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Baylor College of Medicine

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Biogenix Molecular, LLC

    COMPLETED

    Miami, Florida, 33165, United States

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

    RECRUITING

    New York, New York, 10065, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Erasmus MC

    NOT_YET_RECRUITING

    GE Rotterdam, 3015, Netherlands

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fudan University Zhongshan Hospital

    NOT_YET_RECRUITING

    Shanghai, 200032, China

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Indiana University (IU) School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Kyoto University Hospital

    NOT_YET_RECRUITING

    Kyoto, 606-8507, Japan

  • Maastricht University Medical Center

    NOT_YET_RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Cancer Center Hospital East

    NOT_YET_RECRUITING

    Chiba, 277-8577, Japan

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

    NOT_YET_RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • New York University (NYU) Clinical Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Stanford University Medical Center

    RECRUITING

    Stanford, California, 94305, United States

  • Stichting Radboud Universitair Medisch Centrum

    NOT_YET_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Texas Oncology - DFW (Sammons CC)

    RECRUITING

    Dallas, Texas, 75246, United States

  • United Theranostics

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Universitaetsklinikum Essen

    NOT_YET_RECRUITING

    Essen, 45147, Germany

  • Universitair Medisch Centrum Utrecht

    NOT_YET_RECRUITING

    Utrecht, 3584CX, Netherlands

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Wisconsin - Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

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