Tolerance and Pharmacokinetics of TQB2450
Phase I Study of Tolerance and Pharmacokinetics of TQB2450 Injection
Studieöversikt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Studietyp
Studietyp
Inskrivning (Förväntat)
Inskrivning
Fas
Fas
- Fas 1
Deltagandekriterier
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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;
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Antal vapen
Vapen och interventioner
Deltagargrupp / ArmDeltagargrupp / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Experimentell: TQB2450
|
Pharmacokinetics/Dynamics Study
|
Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
dosbegränsande toxicitet (DLT)
Tidsram: 21 dagar
|
21 dagar
|
|
maximum tolerated dose(MTD)
Tidsram: 21 days
|
21 days
|
Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Toppplasmakoncentration (Cmax)
Tidsram: 21 dagar
|
21 dagar
|
|
Topptid (Tmax)
Tidsram: 21 dagar
|
21 dagar
|
|
Halveringstid(t1/2)
Tidsram: 21 dagar
|
21 dagar
|
|
Area under kurvan för plasmakoncentration kontra tid (AUC)
Tidsram: 21 dagar
|
21 dagar
|
|
Klart (CL)
Tidsram: 21 dagar
|
21 dagar
|
|
objective response rate(ORR)
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Studiestart
Primärt slutförande (Förväntat)
Primärt slutförande
Avslutad studie (Förväntat)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Första postat
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
Andra studie-ID-nummer
- TQB2450-I-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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