Clinical Trial

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors

Active, Not Recruiting Phase 1
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Record status
This record was last updated August 13, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy or with sintilimab in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-02-06.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-08-07
Trial Details
NCT Number NCT05718219
Lead Sponsor Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions Advanced Solid Tumors
Enrollment 408 participants
Start Date 2023-03-29
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-13