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RECRUITING
NCT07348211
PHASE1

First in Human Study of SIM0610 in Solid Tumors

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.

Official title: An Open-Label, Multicenter, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0610 in Adult Subjects With Locally Advanced/Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-01-19

Completion Date

2029-07

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

SIM0610 for Injection

intravenous infusion

DRUG

SIM0610 for Injection

intravenous infusion

Locations (7)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

the First Hospital of China Medical University

Shenyang, Liaoning, China

The Affiliated Cancer Hospital of Shandong First Medical University& Shan Dong Cancer Hospital

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China