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
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Voluntary participation and signature of informed consent form;
• Participants should have at least one evaluable or measurable tumor lesion;
• Participants have failed the standard of therapy in the locally advanced/metastatic setting;
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
• Expected survival ≥12 weeks;
• Adequate organ and bone marrow function;
• Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Zhongshan Hospital，Fudan University
NOT_YET_RECRUITING
Shanghai
Tianjin Cancer Hospital
NOT_YET_RECRUITING
Tianjin
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Contact Information
Primary
Jinxiu Zhang
zhangjinxiu@zaiming.com
86-010-65212241
Time Frame
Start Date:2025-11-07
Estimated Completion Date:2029-06
Participants
Target number of participants:232
Treatments
Experimental: A dose escalation of SIM0609
Multiple dose levels of SIM0609 will be explored in dose escalation, and determine the maximum tolerated dose.
Experimental: A dose expansion of SIM0609 -CRC cohort
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)
Experimental: A dose expansion of SIM0609-GC/GEJC cohort
1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC)
Experimental: A dose expansion of SIM0609-PDAC cohort
1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in pancreatic ductal adenocarcinoma (PDAC)
Experimental: A dose expansion of SIM0609-positive other solid tumors cohort
1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in positive other solid tumors