Tolerance and Pharmacokinetics of TQB2450
Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: TQB2450
|
Pharmacokinetics/Dynamics Study
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
dose-limiting toxicity(DLT)
Time Frame: 21 days
|
21 days
|
|
maximum tolerated dose(MTD)
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peak Plasma Concentration(Cmax)
Time Frame: 21 days
|
21 days
|
|
Peak time(Tmax)
Time Frame: 21 days
|
21 days
|
|
Half life(t1/2)
Time Frame: 21 days
|
21 days
|
|
Area under the plasma concentration versus time curve (AUC)
Time Frame: 21 days
|
21 days
|
|
Clearance(CL)
Time Frame: 21 days
|
21 days
|
|
objective response rate(ORR)
Time Frame: evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months)
|
evaluated in the end of each 3 cycles up to intolerance the toxicity or progression disease (up to 24 months)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- TQB2450-I-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tumor
-
NCT04809012WithdrawnSolid Tumor | Relapsed Solid Tumor | Refractory Tumor
-
NCT05661461RecruitingAdvanced Solid Tumor | Tumor | Tumor, Solid
-
NCT06911333RecruitingSolid Tumor | Solid Tumor Cancer | Solid Tumor, Adult | Solid Tumor, Unspecified, Adult | Tumor, Solid | Solid Tumor in Advanced Stage | Solid Tumors Refractory to Standard Therapy
-
NCT03491345Active, not recruitingPD-L1 Positive Mutation Tumor | EBV Positive Mutation Tumor | MSI-H Mutation Tumor | POLE/POLD1 Mutation Tumor
-
NCT06980519AvailableCancer | Solid Tumor | Solid Tumor Cancer | Oncology | uPAR-positive Solid Tumor | Urokinase Plasminogen Activator Receptor-positive Solid Tumor
-
NCT04942717RecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, Adult
-
NCT04537936RecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, Adult
-
NCT04015609RecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, Adult
-
NCT04914117CompletedMetastatic Solid Tumor | Locally Advanced Solid Tumor | Unresectable Solid Tumor
-
NCT05269316RecruitingSolid Tumor | Advanced Solid Tumor
Clinical Trials on TQB2450
-
NCT06469879Not yet recruitingA Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer PatientsSmall Cell Lung Cancer Limited Stage
-
NCT03800706Unknown
-
NCT04306926Not yet recruitingAdvanced Oligometastatic Non-small Cell Lung Cancer
-
NCT04623333Not yet recruitingA Study of TQB2450 Injection in Subjects With PD-L1 Positive Recurrent or Metastatic Cervical CancerRecurrent or Metastatic Cervical Cancer
-
NCT03897283UnknownAdvanced Solid Tumors
-
NCT05252078RecruitingDigestive System Diseases | Gastrointestinal Diseases | Neoplasms by Histologic Type | Neoplasms by Site | Gastrointestinal Neoplasms | Digestive System Neoplasms | Carcinoma, Squamous Cell | Esophageal Neoplasms | Esophageal Diseases | Neoplasms, Squamous Cell
-
NCT05913089Recruiting
-
NCT04325763RecruitingStage III Non-small-cell Lung Cancer
-
NCT07602101Not yet recruitingClear Cell Renal Cell Carcinoma
-
NCT05311319Recruiting