RecruitingPhase 1NCT07618260

SIM0613 in Participants With Advanced Solid Tumors

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

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

294 participants

Start Date

May 15, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Cancer

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SIM0613 and a drug called SIM0613 for people with advanced solid cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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