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NOT YET RECRUITING
NCT07660432
PHASE1

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

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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