Phase II Study of LY4337713 in Patients with FAP‑Positive Solid Tumors (Ovarian, Breast, Pancreatic, Colorectal, Esophageal, Gastric, Cholangiocarcinoma)
- Trial ID
- 2025-521887-37-00
- Protocol
- J6K-OX-JSFA
- Sponsor
- Eli Lilly & Co.
Trial statistics
Diseases & Conditions
Participants
The trial enrolled 177 participants diagnosed with various neoplasms, including ovarian, breast, pancreatic intraductal, colorectal, esophageal, stomach, and cholangiocarcinoma. Both female and male patients were eligible, and enrollment encompassed adult age categories represented by the study’s age range codes 3 and 4. All subjects were classified as patients with confirmed cancer diagnoses, reflecting a generally compromised health status related to malignancy. Selection was based on documented pathology of one of the specified cancer types; additional exclusion criteria were not detailed. Lifestyle factors such as diet, physical activity, or smoking status were not reported in the provided information.
Plans and Procedures
The study is a Phase 1 exploratory investigation of LY4337713 in participants with solid tumors that are fibroblast activation protein (FAP) positive. The trial period extends from August 2026 through July 2033, encompassing enrollment, treatment, and follow‑up activities. Participants undergo a screening visit to confirm eligibility, followed by a baseline visit initiating study drug administration. Subsequent scheduled visits occur at regular intervals to assess safety, pharmacokinetics, and preliminary efficacy, with each visit including physical examination, laboratory testing, and imaging as appropriate. The final visit, designated as the end‑of‑study visit, concludes the participant’s involvement and includes a comprehensive assessment and study drug discontinuation. Participant involvement spans from the initial screening through the end‑of‑study visit, with continued observation until study completion. Early termination may occur if a participant experiences unacceptable toxicity, disease progression that precludes continued assessment, withdrawal of consent, or any protocol‑defined safety concern.
Treatment
No experimental medication or comparator treatments are described in the provided source data.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Germany | Not Yet Recruiting | 18 Aug 2026 | 24 |
The Netherlands | Not Yet Recruiting | 18 Aug 2026 | — |
Netherlands | — | — | 40 |


