Clinical Trial

SIM0613 in Participants With Advanced Solid Tumors

Name: SIM0613 in Participants With Advanced Solid Tumors — clinical trial record (NCT07618260)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SIM0613-101

Recruiting Phase 1

View on ClinicalTrials.gov →

Summary

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Trial Details

NCT Number	NCT07618260
Lead Sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd. Collaborators: Shanghai Xianwei Medical Technology Co., Ltd.
Conditions	Advanced Solid Cancer
Enrollment	294 participants
Start Date	2026-05-15
Primary Completion	2028-06 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-01