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A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
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.
Official title: Phase I First-in-Human, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
472
Start Date
2027-07
Completion Date
2029-06
Last Updated
2026-06-22
Healthy Volunteers
No
Conditions
Interventions
SIM0689 for Injection
SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.
Locations (6)
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
The First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, China