Safety IssuesPhase 1/2TQBSPNCT04690725
TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss
A Phase 1/2 study testing TQB3525 in people with Safety Issues and Efficacy, Self, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Safety Issues, Efficacy, Self
- What is being tested?
- TQB3525
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 1 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas
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.
- Conditions
- Safety Issues, Efficacy, Self
- Being tested
- TQB3525
- Keywords
- osteosarcoma, ewing sarcoma, chondrosarcoma, PI3KA mutation, PTEN loss, TQB3525
- Medical subject headings
- Osteosarcoma, Sarcoma, Ewing, Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3525Drug
TQB3525 is an orally bioavailable, potent, class I kinase inhibitors of PI3Ka and PI3Kd.
| Study group | Role | What they receive |
|---|---|---|
| TQB3525 arm | Experimental | 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 Receives: Drug: TQB3525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity profiles
according to CTCAE 5.0
Measured: 6 months
Secondary outcomes (2)
progression free survival
from starting treatment to progression/death
Measured: 6 months
overall survival
from starting treatment to death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Oct 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- TQB3525 orally taken
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUO WEI, Peking University People's Hospital
- Investigators
- Wei Guo, Ph.D and M.D., Principal investigator, Chinese Sarcoma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690725
- Sponsor's protocol ID
- PKUPH-sarcoma12
- Acronym
- TQBSP
- Status last verified
- Dec 2020
- First submitted
- 25 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of TQB3525, Phosphatidylinositol-3-Kinase α and δ Inhibitors, in Patients With Advanced Bone Sarcomas
- ClinicalTrials.gov ID
- NCT04690725
- Acronym / sponsor ID
- TQBSP / PKUPH-sarcoma12
- Conditions
- Safety Issues, Efficacy, Self
- Keywords
- osteosarcoma, ewing sarcoma, chondrosarcoma, PI3KA mutation, PTEN loss, TQB3525
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TQB3525 orally taken
| Arm | Type | Receives |
|---|---|---|
| TQB3525 arm | Experimental | Drug: TQB35253+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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3525TQB3525 is an orally bioavailable, potent, class I kinase inhibitors of PI3Ka and PI3Kd. | Drug | TQB3525 arm |
Primary outcome
toxicity profiles
Time frame: 6 months
according to CTCAE 5.0
2 secondary outcomes
progression free survival
Time frame: 6 months
overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Guo, Ph.D and M.D. principal investigator
Chinese Sarcoma Study Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB3525 in people with Safety Issues and Efficacy, Self, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
toxicity profiles (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.