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Ovarian NeoplasmsPhase 1FiREBOLTNCT07213791

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

A Phase 1 study testing LY4337713 in people with Ovarian Neoplasms and Breast Neoplasms, run by Eli Lilly and Company at 30 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LY4337713
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
30 sitesin 5 countries
Study dates
22 Oct 2025to Mar 2033
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 25Show fewer
  • Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)
  • Gastric cancer (adenocarcinoma)
  • Colorectal cancer (CRC)
  • Esophageal cancer (squamous cell carcinoma or adenocarcinoma)
  • Cholangiocarcinoma
  • Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
  • 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 1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.
  • Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.
  • Gastric cancer, CRC, esophageal cancer (squamous cell carcinoma or adenocarcinoma), and cholangiocarcinoma: Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; this may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
  • Other non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.
  • 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)

Who cannot join

  • 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).

Trial locations and contacts

30 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

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

30 sites in 5 countries

United States20 sites, 19 recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Not yet recruiting

  • Texas Oncology - DFW (Sammons CC)

    Dallas, Texas, 75246

    Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • United Theranostics

    Glen Burnie, Maryland, 21061

    Recruiting

  • BAMF Health Inc.

    Grand Rapids, Michigan, 49503

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Not yet recruiting

  • Indiana University (IU) School of Medicine

    Indianapolis, Indiana, 46202

    Recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin, 53792

    Recruiting

  • Biogenix Molecular, LLC

    Miami, Florida, 33165

    Completed

  • New York University (NYU) Clinical Cancer Center

    New York, New York, 10016

    Recruiting

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

    New York, New York, 10065

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

    Recruiting

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94305

    Recruiting

  • Moffitt

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

Netherlands6 sites, 6 recruiting

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

    Amsterdam, 1066 CX

    Not yet recruiting

  • Amsterdam UMC - Locatie VUmc

    Amsterdam, 1081 HV

    Not yet recruiting

  • Erasmus MC

    GE Rotterdam, 3015

    Not yet recruiting

  • Maastricht University Medical Center

    Maastricht, 6229 HX

    Not yet recruiting

  • Stichting Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

    Not yet recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584CX

    Not yet recruiting

Other trials in Netherlands

Japan2 sites, 2 recruiting

  • National Cancer Center Hospital East

    Chiba, 277-8577

    Not yet recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507

    Not yet recruiting

Other trials in Japan

China1 site, 1 recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, 200032

    Not yet recruiting

Other trials in China

Germany1 site, 1 recruiting

  • Universitaetsklinikum Essen

    Essen, 45147

    Not yet recruiting

Other trials in Germany

About this study

Official title: A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

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.

Being tested
LY4337713
Keywords
Cancer-associated fibroblasts (CAF), Lutetium-177, LuFAP, Lu-177-FAP
Medical subject headings
Ovarian Neoplasms, Breast Neoplasms, Pancreatic Intraductal Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY4337713Drug

    Administered IV.

Study groups in NCT07213791
Study groupRoleWhat they receive
LY4337713 (Cohort A1)ExperimentalEscalating doses of LY4337713 administered intravenously (IV).
Receives: Drug: LY4337713
LY4337713 (Cohort A2)ExperimentalTwo or more dose regimens of LY4337713 (evaluated during dose escalation) administered IV.
Receives: Drug: LY4337713
LY4337713 (Cohort B)ExperimentalTumor specific cohort will receive LY4337713 administered IV.
Receives: Drug: LY4337713
LY4337713 (Cohort C)ExperimentalTumor specific cohort will receive LY4337713 administered IV.
Receives: Drug: LY4337713
LY4337713 (Cohort D)ExperimentalTumor specific cohort will receive LY4337713 administered IV.
Receives: Drug: LY4337713
LY4337713 (Cohort E)ExperimentalTumor specific cohort will receive LY4337713 administered IV.
Receives: Drug: LY4337713

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities

    Measured: Cycle 1 (28 days)

  2. 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)

    Measured: Baseline through imaging follow-up, up to 5 years

Secondary outcomes (8)

  1. Phase 1a: Absorbed Dose Estimates (Gy) in Normal Organs

    Measured: Baseline through Cycle 4 Day 4 (Cycle = 4 or 6 weeks)

  2. Phase 1a and 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713

    Measured: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)

  3. Phase 1a and 1b: PK: Area Under the Concentration Time Curve (AUC) of LY4337713

    Measured: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)

  4. Phase 1a: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)

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

    Measured: Baseline through imaging follow-up, up to 1 year

  5. Phase 1a and 1b: Number of Participants with Best Overall Response (BOR)

    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.

    Measured: Baseline through imaging follow-up, up to 1 year

  6. Phase 1a and 1b: Duration of Response (DOR)

    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.

    Measured: Baseline through imaging follow-up, up to 5 years

  7. Phase 1a and 1b: Time to Response (TTR)

    Time from first dose date to the date of first documented response of CR or PR

    Measured: Baseline through imaging follow-up, up to 1 year

  8. Phase 1a and 1b: Percentage of Participants with Disease Control Rate (DCR)

    Percentage participants who achieved a BOR of CR, PR, or stable disease (SD), per RECIST v1.1

    Measured: Baseline through imaging follow-up, up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start22 Oct 2025
  3. Primary completionJul 2028 (estimated)
  4. Study completionMar 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213791
Sponsor's protocol ID
27513
Other IDs
J6K-OX-JSFA
Acronym
FiREBOLT
Status last verified
Nov 2026
First submitted
7 Oct 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY4337713 in people with Ovarian Neoplasms and Breast Neoplasms, run by Eli Lilly and Company at 30 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Netherlands, Japan, China, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07213791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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