Overview

Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors

Status:
Not yet recruiting
Trial end date:
2025-12-30
Target enrollment:
Participant gender:
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 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).
Phase:
Phase 1
Details
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.