A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.

NCT Number	NCT07660432
Lead Sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd. Collaborators: Shanghai Xianwei Medical Technology Co., Ltd.
Conditions	Neoplasms, Malignant
Enrollment	472 participants
Start Date	2027-07
Primary Completion	2028-12 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-22