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TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss

NCT ID: NCT04690725

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-06-01

Brief Summary

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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

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Conditions

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Safety Issues Efficacy, Self

Keywords

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osteosarcoma ewing sarcoma chondrosarcoma PI3KA mutation PTEN loss TQB3525

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

TQB3525 orally taken
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

TQB3525

Intervention Type DRUG

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

Interventions

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TQB3525

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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GUO WEI

Director, Head of Msculoskeletal Tumor Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Guo, Ph.D and M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Sarcoma Study Group

Locations

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Peking University Shougang Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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PKUPH-sarcoma12

Identifier Type: -

Identifier Source: org_study_id