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

Official record

Identifier

NCT07213791

Recruiting locations

countries

United StatesChinaGermanyJapanNetherlands

Interventions studied

LY4337713

Lead sponsor

Eli Lilly and Company

Target enrolment

241 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Oct 9, 2025

Last updated on the registry

Sep 22, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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).

Indexed under

Esophageal Cancer