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

NCT06416358 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2024-05-16

No results posted yet for this study

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;

Conditions

  • Advanced Solid Tumors With Bone Only Metastasis

Interventions

DRUG

ALMB-0168

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

Sponsors & Collaborators

  • AlaMab Therapeutics (Shanghai) Inc.

    lead INDUSTRY

Principal Investigators

  • Jingnan Shen, M.D. · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2026-06-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06416358 on ClinicalTrials.gov