ClinicalTrials.gg
RecruitingNCT07213791FiREBOLTUpdated Nov 4, 2026

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

A Phase 1 interventional study of LY4337713 in Ovarian Neoplasms, Breast Neoplasms and Pancreatic Intraductal Neoplasms, sponsored by Eli Lilly and Company. Recruiting at 30 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Updated Nov 4, 2026Site recruiting status changedEnrollment updated+2 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
340
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ovarian Neoplasms
  • Breast Neoplasms
  • Pancreatic Intraductal Neoplasms
  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Cholangiocarcinoma
  • Advanced Solid Tumors

Keywords

  • Cancer-associated fibroblasts (CAF)
  • Lutetium-177
  • LuFAP
  • Lu-177-FAP
03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 340 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment
  • Must have or cytologically confirmed diagnosis of one of the following:

    • Adenocarcinoma of the pancreas
    • Hormone receptor (HR)-positive human epidermal growth factor 2 ()-negative breast cancer
    • HER2-positive breast cancer
    • Triple negative breast cancer (TNBC)
    • Platinum-resistant or 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 disease.
      • HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 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 Performance Status (ECOG PS) of 0 to 1.
  • Measured ≥60 milliliters per minute (mL/min)

Exclusion criteria

Exclusion Criteria:

  • Have known active central nervous system (CNS) or carcinomatous meningitis.
  • Have significant cardiovascular disease
  • Have prolongation of the corrected >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).
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
340 participants (estimated)

Study arms

  • Experimental
    LY4337713 (Cohort A1)

    Escalating doses of LY4337713 administered intravenously (IV).

    Drug: LY4337713

  • Experimental
    LY4337713 (Cohort A2)

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

    Drug: LY4337713

  • Experimental
    LY4337713 (Cohort B)

    Tumor specific cohort will receive LY4337713 administered IV.

    Drug: LY4337713

  • Experimental
    LY4337713 (Cohort C)

    Tumor specific cohort will receive LY4337713 administered IV.

    Drug: LY4337713

  • Experimental
    LY4337713 (Cohort D)

    Tumor specific cohort will receive LY4337713 administered IV.

    Drug: LY4337713

  • Experimental
    LY4337713 (Cohort E)

    Tumor specific cohort will receive LY4337713 administered IV.

    Drug: LY4337713

Interventions

  • DrugLY4337713

    Administered IV.

06

What researchers measure

Primary outcomes

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

    Time frame: 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)

    Time frame: Baseline through imaging follow-up, up to 5 years

Secondary outcomes

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

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

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: Baseline through imaging follow-up, up to 1 year

07

Study locations

17 of 30 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Jul 2028, 33 months after the start.

Of 210 industry-sponsored phase 1 interventional studies under Ovarian Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's planned 33 months is below that.

Counting every sponsor, half of 380 studies reached it within 50 months; a quarter within 32 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2025
First posted
Oct 9, 2025
StartActual
Oct 22, 2025
Primary completionEst.
Jul 2028
CompletionEst.
Mar 2033
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
Mayo Clinic - Rochester is now Recruiting
Nov 4, 2026
Enrollment
241→340
Oct 27, 2026
Eligibility
2 inclusion criteria edited, 2 added, 1 removed
What changed in the criteria
Inclusion criteria
  • RemovedOther solid tumors
  • AddedOther non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
  • EditedTNBC: Participants must have received at least 2 lines1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.
  • EditedOther solid tumors (gastricGastric 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; includingthis may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
  • AddedOther non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.
Oct 27, 2026
Interventions
Arm changed Experimental: LY4337713 (Cohort B)→LY4337713 (Cohort B); Experimental LY4337713 (Cohort C)→LY4337713 (Cohort C); Experimental: LY4337713 (Cohort D)→LY4337713 (Cohort D)
Oct 27, 2026
Secondary outcomes
3 edited
What changed in the outcomes
  • EditedPhase 1a and 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
  • EditedPhase 1a and 1b: PK: Area Under the Concentration Time Curve (AUC) of LY4337713Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
  • EditedPhase 1a and 1b: Number of Participants with Best Overall Response (BOR)Time frame: Baseline through imaging follow-up, up to 1 year
Oct 27, 2026
Show all 2 updates
  1. Nov 4, 2026
    Mayo Clinic - Rochester is now Recruiting
    + 1 other change: verification date
  2. Oct 27, 2026
    Enrollment 241→340
    Eligibility 2 inclusion criteria edited, 2 added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • RemovedOther solid tumors
    • AddedOther non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),
    • EditedTNBC: Participants must have received at least 2 lines1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.
    • EditedOther solid tumors (gastricGastric 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; includingthis may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.
    • AddedOther non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.
    Secondary outcomes 3 edited
    What changed in the outcomes
    • EditedPhase 1a and 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4337713Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
    • EditedPhase 1a and 1b: PK: Area Under the Concentration Time Curve (AUC) of LY4337713Time frame: Cycle 1 Day 1 up to Cycle 2 Day 4 post dose (Cycle = 4 or 6 weeks)
    • EditedPhase 1a and 1b: Number of Participants with Best Overall Response (BOR)Time frame: Baseline through imaging follow-up, up to 1 year
    Interventions Arm changed Experimental: LY4337713 (Cohort B)→LY4337713 (Cohort B); Experimental LY4337713 (Cohort C)→LY4337713 (Cohort C); Experimental: LY4337713 (Cohort D)→LY4337713 (Cohort D)
    + 2 other changes: verification date and conditions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07213791
Responsible party
Sponsor
First posted
Oct 9, 2025
Start date
Oct 22, 2025
Primary completion
Jul 2028 (estimated)
Completion
Mar 2033 (estimated)
Last update
Nov 4, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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