A Study of LY4337713 for FAP-Positive Solid Tumors
This study is testing a drug called LY4337713 for people with certain advanced or spreading cancers, including ovarian, breast, pancreatic, colorectal, and esophageal cancers. To join, your cancer must have high levels of a protein called fibroblast activation protein (FAP). LY4337713 is an antibody-drug conjugate (a targeted therapy that delivers medicine directly to cancer cells) and an immunotherapy. Researchers want to learn about the safety and side effects of LY4337713, how well it works, and how your body handles the drug. The study will follow participants for about 5 years. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 241 participants. It is testing the drug LY4337713, which is given intravenously (through a vein).
- What's involved
- You would receive LY4337713 and be followed for about 5 years. This includes imaging follow-up to check how your cancer responds.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after starting treatment to monitor how their cancer responds.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07213791
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentEli Lilly and Company
~241 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:LY4337713
At a glance
Recruiting sites
15 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities
Measured over Cycle 1 (28 days)
+1 more outcome measured
Conditions
Where it's being run
30 sites across 17 statesNetherlands6
California2
Florida2
Massachusetts2
Michigan2
New York2
Pennsylvania2
Texas2
Study leadership
- 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
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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).
What this trial measures
- Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) ToxicitiesCycle 1 (28 days)
- Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)Baseline through imaging follow-up, up to 5 years
Per investigator assessed Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)