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RECRUITING
NCT07618260
PHASE1

SIM0613 in Participants With Advanced Solid Tumors

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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).

Official title: A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0613 in Participants With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2026-05-15

Completion Date

2028-12

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

SIM0613

Administered as an intravenous infusion in dosing cycles

DRUG

SIM0613

Administered as an intravenous infusion in dosing cycles

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China