A Phase 2 Study of LY4257496 in Participants with Advanced or Metastatic Solid Tumors Including Breast, Colorectal, Prostate, and Endometrial Neoplasms
- Trial ID
- 2025-522367-15-00
- Protocol
- J6C-OX-JKFA
- Sponsor
- Eli Lilly & Co.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the efficacy and safety of LY4257496 in participants diagnosed with various malignancies, including breast neoplasms, colorectal neoplasms, prostate neoplasm, endometrial neoplasms, and neoplasm metastasis.
Participants
The study involves a total of 368 patients. The participant population consists of both males and females within the age range of 3 to 4 years. Included individuals are characterized by the presence of breast neoplasms, colorectal neoplasms, prostate neoplasm, endometrial neoplasms, or neoplasm metastasis.
Plans and Procedures
This Phase 1 clinical trial evaluates the efficacy and safety of LY4257496 in individuals diagnosed with various types of cancer, including breast cancer, colorectal cancer, prostate cancer, endometrial cancer, and metastatic neoplasm. The study follows a specific research methodology to monitor the pharmacological effects of the investigational product. The procedure begins with a screening visit to determine eligibility based on predefined criteria. Subsequent follow-up visits are conducted to assess clinical outcomes and safety parameters. The protocol concludes with an end-of-study visit. Total participant involvement is subject to the clinical progression and safety protocols established for the study. Early termination from the trial may occur if specific medical conditions or safety concerns arise during the observation period.
Treatment
Efficacy
The assessment of efficacy in this clinical trial involves the evaluation of various types of neoplasms, including breast cancer, colorectal cancer, prostate cancer, and endometrial cancer, as well as neoplasm metastasis. Specific parameters for determining therapeutic response are not defined in the provided documentation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Germany | Not Yet Recruiting | 15 May 2026 | 53 |

