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Advanced Malignant TumorPhase 1NCT04975204

A Clinical Trial of TQB3909 Tablets in Subjects With Advanced Malignant Tumors

A Phase 1 study testing TQB3909 Tablets in people with Advanced Malignant Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Tumor
What is being tested?
TQB3909 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesChina
Study dates
18 Feb 2022to Aug 2024
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects volunteered to join the study and signed informed consent form (ICF)with good compliance.
  • Age: ≥ 18 years old (when signing ICF); Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1; The expected survival period is more than 3 months.
  • Advanced malignant tumor diagnosed by histology or cytology.
  • Relapse or failure after previous standard treatment, or intolerance to standard treatment, and no other better treatment options.
  • Subject population:a)Dose escalation stage: non-Hodgkin's lymphoma;b) Dose expansion stage: non-Hodgkin's lymphoma, plasmacytoma, acute myeloid leukemia, myelodysplastic syndrome, etc.
  • At least 1 lesion / measurable disease for efficacy evaluation.
  • The function of main organs are well, and the following examination results are good: routine blood examination, biochemical examination, blood coagulation function examination, and heart color Doppler ultrasound evaluation.
  • Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine device, contraceptive or condom) during the study period and within 6 months after the end of the study; The serum pregnancy test iss negative within 7 days before the enrollment and must be non-lactating subjects; Male subjects should agree to avoid childbirth during the study period and within 6 months after the end of the study period.

Who cannot join

  • Combined disease and History:
  • There were other malignant tumors in 3 years before the first medication. The following two cases can be included: other malignant tumors treated by single operation have achieved 5-year disease-free survival (DFS) in a row; The cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
  • The diagnosis was Burkitt lymphoma, lymphoblastic lymphoma / leukemia, etc;
  • Central nervous system (CNS) invasion was found;
  • He has received allogeneic hematopoietic stem cell transplantation in the past;
  • Autologous hematopoietic stem cell transplantation was performed 3 months before the first administration;
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  • There are many factors influencing oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
  • Unrelieved toxicity of ≥ circulating tumor cells(CTC) AE 1 due to any previous treatment, excluding alopecia;
  • Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study;
  • There are active or uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA), idiopathic thrombocytopenic purpura (ITP), etc;
  • Arteriovenous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
  • Have a history of psychotropic drug abuse and can not quit or have mental disorders;
  • Subjects with any severe and / or uncontrolled disease included:
  • Patients with ≥ 2 grade myocardial ischemia 6 months between the first administration or myocardial infarction, arrhythmia (male corrected QT interval (QTc) > 450ms, female QTc > 470ms) and ≥ 2 grade congestive heart failure (NYHA classification), Cardiac color Doppler ultrasound to evaluate left ventricular ejection fraction（LVEF）<50%;
  • There was active severe infection (≥ CTC AE grade 2 infection);
  • Fever and neutropenia were found within 1 week before the first medication;
  • Diabetes was poorly controlled (fasting blood glucose (FBG) > 10mmol/L).
  • Active hepatitis *;
  • active hepatitis (hepatitis B reference: hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus(HBV) DNA detection value > 2000 copies /mL or 500 internation unit (IU)/mL; Hepatitis C reference: hepatitis C virus(HCV) antibody was positive, and HCV titer detection value exceeded the upper limit of normal value);
  • History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation;
  • Patients with epilepsy and need treatment.
  • tumor related symptoms and treatment:
  • Subjects who have received chemotherapy, radiotherapy within 4 weeks prior to the first dose or received immune checkpoint inhibitors and CAR-T treatment 12 weeks before the first medication, or other anti-tumor treatment within 5 half-life prior to the first dose (the washing and removing period is calculated from the end of the last treatment) ;
  • Subjects who have previously received BCL-2 inhibitors.
  • Subjects who have received the vaccine within 4 weeks prior to the first dose, or is planning to be vaccinated during the study period.
  • Subjects who have participated in clinical trials of other anti-tumor drugs within 4 weeks before the first dose.
  • According to the judgment of the investigator, subjects with concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons which are not suitable for inclusion.

Trial locations and contacts

2 sites in 1 country.

Jianyong Li, Doctor contact

13951877733

lijianyonglm@126.com

Wei Xu, Doctor contact

13951699449

xuwei0484@jsph.org.cn

China2 sites, 2 recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029

    Jianyong Li, Doctor, 13951877733, lijianyonglm@126.com

    Wei Xu, Doctor, 13951699449, xuwei0484@jsph.org.cn

    Recruiting

  • Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences &Peking Union Medical College

    Tianjin, Tianjin Municipality, 300041

    Jianxiang Wang, Doctor, 022-23909278, wangjx@ihcams.ac.cn

    Junyuan Qi, Doctor, 022-23909067, qijy@ihcams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial Evaluating the Tolerance and Pharmacokinetics of TQB3909 Tablets in Patients With Relapsed or Refractory Advanced Malignant Tumors

TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2 associated death (BAD) protein, promotes the release of cytochrome c from mitochondria, phosphatidylserine eversion, stimulates caspase 3 / 7 activity and caspase 3 / 9 cleavage, and induces apoptosis.

Being tested
TQB3909 Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3909 TabletsDrug

    TQB3909 is an inhibitor targeting BCL-2 protein

Study groups in NCT04975204
Study groupRoleWhat they receive
TQB3909 TabletsExperimentalTake 100-1200mg once a day; Oral administration on an empty stomach, 28 days as a cycle.
Receives: Drug: TQB3909 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity（DLT）

    DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

    Measured: up to 18 months

  2. Recommended Phase II Dose (RP2D)

    DLT describes side effects of a drug or other treatment that are serious enough to To evaluate RP2D of TQB3909 tablets in adult patients with advanced solid tumors

    Measured: up to 18 months

Secondary outcomes (21)

  1. Adverse events (AEs) and serious adverse events (SAEs)

    The incidence and severity of AEs and SAEs, as well as abnormal laboratory test indicators.

    Measured: up to 18 months

  2. Time to reach maximum(peak )plasma concentration following drug administration (Tmax)

    To characterize the pharmacokinetics of TQB3909 by assessment of time to reach maximum plasma concentration after single and multiple dosing

    Measured: Within 32 weeks after administration

  3. Maximum (peak) plasma drug concentration (Cmax)

    Cmax is the maximum plasma concentration of TQB3909.

    Measured: Within 24 hours after administration

  4. Maximum (peak) steady-state plasma drug concentration during a dosage interval (Css-max)

    Css-max is the steady state maximum concentration of TQB3909 .

    Measured: Within 32 weeks after administration

  5. Area under the plasma concentration-time curve from time zero to time t (AUC0-t)

    To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.

    Measured: Within 24 hours after administration

  6. Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)

    To characterize the pharmacokinetics of TQB3909 by assessment of area under the plasma concentration time curve from the first dose to infinity.

    Measured: Within 24 hours after administration

  7. Area under the plasma concentration-time curve when reaching steady state (AUCss)

    AUCss is the area under the curve of TQB3909.

    Measured: Within 32 weeks after administration

  8. Apparent total clearance of the drug from plasma after oral administration (CL/F)

    CL/F is total clearance rate for TQB3909.

    Measured: Within 24 hours after administration

  9. Elimination half-life (t1/2)

    t1/2 is time it takes for the blood concentration of TQB3909 to drop by half.

    Measured: Within 24 hours after administration

  10. Mean residence time (MRT)

    MRT describes the average time that TQB3909 remains in the body.

    Measured: Within 24 hours after administration

  11. Minimum steady-state plasma drug concentration during a dosage interval (Css-min)

    Css-min is the minimum plasma concentration of TQB3909.

    Measured: Within 32 weeks after administration

  12. Degree of fluctuation(DF)

    DF is the volatility coefficient of TQB3909.

    Measured: Within 32 weeks after administration

  13. Average steady-state plasma drug concentration during multiple-dose administration (Css-av)

    Css-av is the average of steady-state plasma concentration of TQB3909 .

    Measured: Within 32 weeks after administration

  14. Apparent volume of distribution after non-intervenous administration (Vd/F)

    Vd/F is the bioavailability corrected apparent distribution volume of TQB3909

    Measured: Within 24 hours after administration

  15. Progression-free survival (PFS)

    PFS is defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

    Measured: up to 18 months

  16. Overall response rate (ORR)

    Percentage of participants achieving complete response (CR) and partial response (PR).

    Measured: up to 18 months

  17. Complete response rate（CRR）

    CRR refers to the percentage of patients who enter the clinical disappearance period of the disease after a certain treatment.

    Measured: up to 18 months

  18. Disease control rate（DCR）

    Percentage of participants achieving CR and PR and stable disease (SD).

    Measured: up to 18 months

  19. Duration of Response (DOR)

    The period from the participants first achieving CR or PR to disease progression.

    Measured: up to 18 months

  20. Overall survival (OS)

    OS is defined as the time from the first administration to all-cause death.

    Measured: up to 18 months

  21. Protein concentration or gene expression level related to BCL-2 signaling pathway

    To evaluate the changes of BCL-2 signaling pathway related to proteins or genes.

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2021
  2. Study start18 Feb 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04975204
Sponsor's protocol ID
TQB3909-I-01
Status last verified
Mar 2022
First submitted
14 Jul 2021
Last updated
7 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB3909 Tablets in people with Advanced Malignant Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 8 inclusion and 27 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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.

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?

Contact Jianyong Li, Doctor (13951877733, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity（DLT） (time frame: up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04975204.

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 7 Mar 2022.

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