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TumorPhase 1NCT03460457

Tolerance and Pharmacokinetics of TQB2450

A Phase 1 study testing TQB2450 in people with Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Tumor
What is being tested?
TQB2450
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
15 Mar 2018to 15 Mar 2019
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced malignancy diagnosed with pathology or cytology who have failed standard treatment or no standard treatment;
  • 18-70 years old;Eastern Cooperative Oncology Group performance status:0-1,Life expectancy of more than 3 months;
  • Main organs function is normal;
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;
  • Patients should be voluntary and sign the informed consents before taking part in the study;

Who cannot join

  • Patients who have received programmed cell death protein 1(PD-1) or programmed cell death protein ligand(PD-L1) antibody treatment;
  • Patients who had any> 3 degree immune-related adverse event during any previous immunotherapy received;
  • Appeared severe hypersensitivity after taking other monoclonal antibody drugs;
  • Other malignancies have been diagnosed in the past 2 years except cured or locally curable cancers, such as cutaneous or squamous cell carcinoma, superficial bladder cancer, cervical cancer or orthotopic carcinoma of the breast;
  • Known spinal cord compression, cancer meningitis patients, new onset of central nervous system metastasis or stable control of symptoms in patients with brain metastases less than 4 weeks; asymptomatic and stable imaging without the need for corticosteroid treatment；
  • Patients with hypothyroidism over 2 degrees;
Show all 19Show fewer
  • Patients with active, or who have had, and are likely to relapse, autoimmune diseases; the following patients are enrolled: skin disorders without systemic treatment (eg vitiligo, psoriasis, hair loss);
  • Patients treated with glucocorticoids or other immunosuppressive agents within 4 weeks prior to dosing;
  • Interstitial lung disease or non-contagious pneumonia (including past history and current illness); uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. except for radiotherapy-induced interstitial pneumonitis;
  • Serious chronic or active infections require systemic antibacterial, antifungal or antiviral treatment (allowing antiviral treatment in patients with hepatocellular carcinoma), including tuberculosis infection;
  • Unstable pleural effusion, pericardial effusion or ascites;
  • Significant cardiovascular diseases such as heart failure of New York Heart Academy(NYHA) Class 2 and above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval ≥480 ms) or unstable Angina;
  • Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
  • Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication;
  • Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C;
  • The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;
  • The first medication interval from the patient: the last chemotherapy for at least 4 weeks, biological products at least five half-lives;
  • Inoculated with vaccine or attenuated vaccine within 4 weeks before first administration;
  • Major surgery, or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;

About this study

Official title: Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection

To study the pharmacokinetic characteristics of TQB2450 in the human body, recommend a reasonable regimen for subsequent research.

Conditions
Tumor
Being tested
TQB2450
Medical subject headings
Neoplasms

What participants receive

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

  • TQB2450Drug

    Pharmacokinetics/Dynamics Study

Study groups in NCT03460457
Study groupRoleWhat they receive
TQB2450ExperimentalNot described
Receives: Drug: TQB2450

What is being measured

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

  1. maximum tolerated dose(MTD)

    Measured: 21 days

  2. dose-limiting toxicity(DLT)

    Measured: 21 days

Secondary outcomes (6)

  1. Peak Plasma Concentration(Cmax)

    Measured: 21 days

  2. Peak time（Tmax）

    Measured: 21 days

  3. Half life（t1/2）

    Measured: 21 days

  4. Area under the plasma concentration versus time curve (AUC)

    Measured: 21 days

  5. Clearance（CL）

    Measured: 21 days

  6. objective response rate(ORR)

    Measured: evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months)

Timeline

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

  1. First posted9 Mar 2018
  2. Study start15 Mar 2018 (estimated)
  3. Primary completion15 Mar 2019 (estimated)
  4. Study completion15 Mar 2019 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03460457
Sponsor's protocol ID
TQB2450-I-01
Status last verified
Mar 2018
First submitted
26 Feb 2018
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Xue J, Xue L, Tang W, Ge X, Zhao W, Li Q, Peng W, Dai C, Guo Y, Li J. TQB2450 in patients with advanced malignant tumors: results from a phase I dose-escalation and expansion study. Ther Adv Med Oncol. 2024 Jan 6;16:17588359231220516. doi: 10.1177/17588359231220516. eCollection 2024.

    PubMed 38188467

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB2450 in people with Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..

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 19 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

maximum tolerated dose(MTD) (time frame: 21 days). 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 NCT03460457, which also lists 1 linked publication.

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 9 Mar 2018.

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