Clinical Trial

First in Human Study of SIM0610 in Solid Tumors

Study acronym: SIM0610-101
Recruiting Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-09.
Trial Details
NCT Number NCT07348211
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators: Shanghai Xianwei Medical Technology Co., Ltd.
Conditions Advanced Solid Tumours, Non-Small Cell Lung Cancer, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Hepatocellular Carcinoma
Enrollment 260 participants
Start Date 2026-01-19
Primary Completion 2027-12 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-23