NCT06416358

A Study to Evaluate the Efficacy of ALMB-0168 in Solid Tumor Patients With Bone Metastatic Whose Prior Standard Treatment Have Failed

A Phase IIa, Multi-center, Single-Arm, Open-Label Study to Evaluate the Efficacy of ALMB-0168 in Solid Tumor Patients With Bone Metastatic Whose Prior Standard Treatment Have Failed

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: AlaMab Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Bone metastasis is a common disease of advanced tumors. It refers to the metastasis of malignant tumors originating in a certain organ to the bones through the blood circulation or lymphatic system. The incidence of bone metastasis in breast 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). SRE caused by bone metastasis of tumors can greatly reduce the quality of life of tumor patients. In severe cases, it can lead to rapid deterioration of the condition or even death, which greatly affects the extension of the patient's survival period. ALMB-0168 is designed to activate Cx43 hemichannels, which release key anti-cancer factors (such as ATP) into the extracellular environment. In several mouse models of breast cancer bone metastasis and orthotopic osteosarcoma, ALMB-0168 dose-dependently inhibited tumor growth and was able to extend the lifespan of tumor-bearing animals, indicating its potential as a therapeutic drug for malignant bone tumors. . Clinical research data from China and Australia show that ALMB-0168 is safe and initially effective in patients with bone metastasis and osteosarcoma;

Detailed description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

Conditions

• Advanced Solid Tumors With Bone Only Metastasis

Interventions

Type	Name	Description
DRUG	ALMB-0168	ALMB-0168 will be administered intravenously until either the disease progresses or intolerable toxicity occurs.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-05-16
• Last updated: 2024-05-16