Overview

First in Human Study of SIM0610 in Solid Tumors

Status:
RECRUITING
Trial end date:
2029-07-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborator:
Shanghai Xianwei Medical Technology Co., Ltd.
Treatments:
Injections