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Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

3+3 design for phase I for RP2D (Recommended Phase 2 Dose) for adolescents (12-17 years old) (15mg QD or 20mg QD); phase II for efficacy exploration for another 17 patients using RP2D QD

TQB3525 is an orally bioavailable, potent, class I kinase inhibitors of PI3Ka and PI3Kd.

TQB3525

Wei Guo, Ph.D and M.D.

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.

TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss

Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas

from starting treatment to progression/death

Peking University People's Hospital

Director, Head of Msculoskeletal Tumor Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss	NCT04690725	Safety Issues Efficacy, Self	TQB3525	12 Years -	Peking University People's Hospital
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss	NCT04690725	Safety Issues Efficacy, Self	TQB3525	12 Years -	Peking University People's Hospital

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