RecruitingPhase 1NCT07265921

A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Enrollment

232 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Cancer

Summary

This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SIM0609 for injection, a drug called dose expansion of SIM0609 in CRC, and others for people with advanced solid cancer. The study is currently recruiting participants at 6 locations. 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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Interventions

DRUGSIM0609 for injection

Multiple dose levels of SIM0609 will be explored in dose escalation

DRUGdose expansion of SIM0609 in CRC

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)

DRUGdose expansion of SIM0609 in GC/GEJC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort

DRUGdose expansion of SIM0609 in PDAC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort

DRUGdose expansion of SIM0609 in positive other solid tumors

1\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort