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A Study 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
2026-07-15
Completion Date
2030-12-31
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
LM-364 for injection
Q3W, Intravenous Drip
Tislelizumab
Q3W, Intravenous Drip
Locations (3)
Macquarie University
North Ryde, New South Wales, Australia
Cancer Care Wollongong Hospital
Wollongong, New South Wales, Australia
Icon Cancer Centre South Brisbane
Brisbane, Queensland, Australia