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A Phase I/II of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
Sponsor: LaNova Medicines Limited
Summary
For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors. For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
Official title: A Phase I/II, First-in-Human (FIH), Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM-364 as a Single Agent or in Combination With Anti-tumor Therapy in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-10-19
Completion Date
2031-08-19
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
LM-364 for injection
Q3W, Intravenous infusion
Tislelizumab
Q3W, Intravenous infusion
Locations (8)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
the first affiliated hospital of Henan medical University
Xinxiang, Henan, China
Taihe Hospital Affiliated Hospital of Hubei University of Medicine
Shiyan, Hubei, China
Hunan cancer hospital
Changsha, Hunan, China
Hunan cancer hospital
Changsha, Hunan, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The First School of Medicine, School of Information and Engineering,The First Affliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China