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NCT Number: NCT07213791

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

LY4337713

Drug

Administered IV.

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)

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

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

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: 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: 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)

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

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

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

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

    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.

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

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

    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.

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

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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)

Acronym: FiREBOLT

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Oct 9, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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