A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
NCT07660432 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 472
Last updated 2026-06-22
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.
Conditions
- Neoplasms, Malignant
Interventions
- DRUG
-
SIM0689 for Injection
SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.
Sponsors & Collaborators
-
Shanghai Xianwei Medical Technology Co., Ltd.
collaborator UNKNOWN -
Jiangsu Simcere Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-07-31
- Primary Completion
- 2028-12-31
- Completion
- 2029-06-30
Countries
- China
Study Locations
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