Spots Global Cancer Trial Database for TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss
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Trial Identification
Brief Title: TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss
Official Title: Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas
Study ID: NCT04690725
Interventions
Study Description
Brief Summary: The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. The PI3K-AKT-mTOR axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. PI3Ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. Other causes of pathway hyperactivation include loss of function of the tumor suppressor PTEN, gain-of-function mutations in AKT and PDK1, or upregulation of receptor tyrosine kinases. TQB3525 is an orally bioavailable, potent, dual catalytic site inhibitor of PI3Ka and PI3Kd. Tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with PI3K-mutant, PTEN-null cell lines. The investigators try to investigate TQB3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (DLT), MTD and antitumor efficacy.
Detailed Description:
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University Shougang Hospital, Beijing, , China
Contact Details
Name: Wei Guo, Ph.D and M.D.
Affiliation: Chinese Sarcoma Study Group
Role: PRINCIPAL_INVESTIGATOR
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