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TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss (TQBSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04690725
Recruitment Status : Unknown
Verified December 2020 by GUO WEI, Peking University People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Information provided by (Responsible Party):
GUO WEI, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Safety Issues Efficacy, Self Drug: TQB3525 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: TQB3525 orally taken
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Arm Intervention/treatment
Experimental: TQB3525 arm
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
Drug: TQB3525
TQB3525 is an orally bioavailable, potent, class I kinase inhibitors of PI3Ka and PI3Kd.

Primary Outcome Measures :
  1. toxicity profiles [ Time Frame: 6 months ]
    according to CTCAE 5.0

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 6 months ]
    from starting treatment to progression/death

  2. overall survival [ Time Frame: 2 years ]
    from starting treatment to death

Other Outcome Measures:
  1. fasting triglyceride [ Time Frame: 6 months ]
    dynamic changes from Peripheral Blood

  2. fasting lipoprotein [ Time Frame: 6 months ]
    dynamic changes from Peripheral Blood

  3. fasting insulin [ Time Frame: 6 months ]
    dynamic changes from Peripheral Blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • progression upon first-line chemotherapy;
  • with target lesions according to RECIST 1.1;
  • geno-profiling with PI3KA mutations or PTEN loss;
  • ECOG PS status 0 or 1 with a life expectancy >3 months;
  • adequate renal, hepatic, and hematopoietic function;

Exclusion Criteria:

  • been previously exposed to other TKIs;
  • had central nervous system metastasis;
  • had other kinds of malignant tumors at the same time;
  • had cardiac insufficiency or arrhythmia;
  • had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++, and so on;
  • had pleural or peritoneal effusion that needed to be handled by surgical treatment;
  • had other infections or wounds;
  • pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04690725

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Peking University Shougang Hospital
Beijing, China, 100036
Sponsors and Collaborators
Peking University People's Hospital
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Principal Investigator: Wei Guo, Ph.D and M.D. Chinese Sarcoma Study Group
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Responsible Party: GUO WEI, Director, Head of Msculoskeletal Tumor Center, Peking University People's Hospital Identifier: NCT04690725    
Other Study ID Numbers: PKUPH-sarcoma12
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GUO WEI, Peking University People's Hospital:
ewing sarcoma
PI3KA mutation
PTEN loss
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue