Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Tolerance and Pharmacokinetics of TQB2450

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Fase 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TQB2450
Pharmacokinetics/Dynamics Study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
dosisbegrænsende toksicitet (DLT)
Tidsramme: 21 dage
21 dage
maximum tolerated dose(MTD)
Tidsramme: 21 days
21 days

Sekundære resultatmål

Resultatmål
Tidsramme
Maksimal plasmakoncentration (Cmax)
Tidsramme: 21 dage
21 dage
Spidstid (Tmax)
Tidsramme: 21 dage
21 dage
Halveringstid(t1/2)
Tidsramme: 21 dage
21 dage
Arealet under plasmakoncentrationen versus tidskurven (AUC)
Tidsramme: 21 dage
21 dage
Klarering (CL)
Tidsramme: 21 dage
21 dage
objective response rate(ORR)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

15. marts 2018

Primær færdiggørelse (Forventet)

15. marts 2019

Studieafslutning (Forventet)

15. marts 2019

Datoer for studieregistrering

Først indsendt

26. februar 2018

Først indsendt, der opfyldte QC-kriterier

2. marts 2018

Først opslået (Faktiske)

9. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TQB2450-I-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Svulst

Kliniske forsøg med TQB2450

Abonner