NCT07265921

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Solid Cancer

Interventions

Type	Name	Description
DRUG	SIM0609 for injection	Multiple dose levels of SIM0609 will be explored in dose escalation
DRUG	dose 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)
DRUG	dose expansion of SIM0609 in GC/GEJC cohort	1\~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort
DRUG	dose expansion of SIM0609 in PDAC cohort	1\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort
DRUG	dose expansion of SIM0609 in positive other solid tumors	1\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort

Timeline

• Start date: 2025-11-07
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study