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NOT YET RECRUITING
NCT07847905
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

LM-364 for injection

Q3W, Intravenous infusion

DRUG

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