Shanghai Enlemai Biotechnology Co., Ltd.

Bone metastasis is a common disease in advanced tumors. It refers to the metastasis of malignant tumors originating in a certain organ to the bone through the blood circulation or lymphatic system. The incidence of bone metastasis in breast cancer and prostate cancer is as high as 65%-75%. Bone metastasis of malignant tumors often leads to severe bone lesions, including bone pain, pathological fractures, spinal cord compression, hypercalcemia and other bone-related events (SRE). SREs caused by tumor bone metastasis can greatly reduce the quality of life of tumor patients. In severe cases, it can lead to a sharp deterioration of the disease or even death, greatly affecting the extension of the patient's survival period. ALMB-0168 is designed to activate Cx43 hemichannels and release key anti-cancer factors (such as ATP) into the extracellular environment by activating Cx43 hemichannels. In several mouse models of breast cancer bone metastasis and orthotopic osteosarcoma, ALMB-0168 inhibited tumor growth in a dose-dependent manner and was able to prolong the life of tumor-bearing animals, indicating its potential as a therapeutic drug for malignant bone tumors. Clinical research data from China and Australia showed that ALMB-0168 has good safety and is initially effective in patients with tumor bone metastasis and osteosarcoma;

The primary study objective is to evaluate the safety and tolerability of a single dose of ALMB-0166 in patients with acute spinal cord injury. Secondary study objectives include evaluating the pharmacokinetic characteristics, preliminary efficacy, and immunogenicity of a single dose of ALMB-0166.

Primary objective: Part I is to evaluate the safety and tolerability of ALMB-0168 in patients with osteosarcoma who have failed standard treatment, and to explore the Phase II recommended dose (RP2D); Part II is to further evaluate the safety and efficacy of ALMB-0168 in patients with high-grade osteosarcoma who have failed standard treatment, and to further determine the RP2D. Secondary objectives: Part I is to evaluate the pharmacokinetic (PK) characteristics and immunogenicity of ALMB-0168, and to preliminarily evaluate the efficacy of ALMB-0168 in the treatment of osteosarcoma patients; Part II is to further evaluate the PK characteristics and immunogenicity of ALMB-0168.