- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04979390
Safety, Tolerability and Pharmacokinetics of the New Formulation SHR-1316 in Subjects With Advanced Tumors
16. juli 2021 opdateret af: Jiangsu HengRui Medicine Co., Ltd.
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of New Formulation SHR-1316 in Subjects With Advanced Tumors
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of the new formulation SHR-1316 in subjects with advanced tumors.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
15
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Wen Jing
- Telefonnummer: 17721286191
- E-mail: wen.jing@hengrui.com
Undersøgelse Kontakt Backup
- Navn: Yuya Wang
- Telefonnummer: 13918749176
- E-mail: yuya.wang@hengrui.com
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥18 years.
- Histologically or cytologically confirmed advanced cancer in patients who are fail to current standard therapy or lack of effective therapy.
- Estimated life expectancy ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ functions.
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment dose.
- Patients must be willing and able to provide written informed consent prior to the performance of any study-specific procedure.
Exclusion Criteria:
- Known history of hypersensitivity to any components of the SHR-1316 product.
Patient- Prior treatment with the following agents:
- "Check-point inhibitors", including Programmed death receptor-1 (PD-1), PD-L1;
- Receipt of investigational agents within 4 weeks prior to study treatment;
- Current treatment on another therapeutic clinical trial, unless the observational (non-interventional) clinical trials or follow-up of interventional clinical trials;
- Any anti-cancer therapy (including chemotherapy, immunotherapy, hormone therapy, target therapy, biotherapy or tumor embolization), administered within 4 weeks prior to study treatment; or within 6 weeks in the case of certain therapies (e.g., mitomycin C and nitrosoureas). Any such, unless discussed and explained with the sponsor;
- Anticipated need for any anti-cancer therapy (including chemotherapy, immunotherapy, hormone therapy, or biotherapy) during SHR-1316 treatment; except palliative radiotherapy;
- Receipt of any anti-cancer vaccines; receipt of immunomodulatory drugs within 4 weeks prior to study treatment; topical, nasal spray and inhaled corticosteroids as well as systemic steroid therapy in physiological doses (such as: prednisone ≤10 mg/day) are acceptable.
- Patients have unrecovered (ie, to NCI CTCAE grade ≤1) from all toxicity associated with previous treatments (exception: patients may enter with continuing alopecia irrespective of CTCAE grade; grade 2 peripheral nerve diseases).
- Known Active central nervous system (CNS) metastases; Patients who had previously received brain or meningeal metastasis therapy, who were clinically stable for at least 8 weeks, and who had stopped systemic sex hormone therapy (such as: prednisone > 10 mg/day) for more than 4 weeks were included.
- Subjects with active autoimmune disease, history of autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
- Active or history of immune deficiency, such as human immunodeficiency virus (HIV) infection; History of organ transplantation.
- History or evidence of cardiovascular (CV) risk including any of the following: Congestive heart failure (Class >2) as defined by the New York Heart Association functional classification system (NYHA), unstable angina pectoris, Recent (within the past 12 months) history of myocardial infarction, clinically significant supraventricular or ventricular arrhythmias need treatment or intervention.
- Patients with clinically significant ECG abnormalities (QT interval corrected for rate by Fridericia's formula [QTcF] >470 msec for female and >450 msec for male on the ECG obtained at Screening).
- Active infection that need drug intervention or an unexplained fever >38.5°C (fever caused by cancer can be included according to the judgement of the researcher).
- Active pulmonary tuberculosis infection.
- Positive for Hepatitis B or C.
- Known history of psychoactive drug abuse, alcohol abuse or drug use.
- Known history of any other malignant cancer within past 3 years. Exceptions: completely resected basal cell carcinoma and squamous cell carcinoma of the skin; and completely resected carcinoma in situ of cervix.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Behandlingsgruppe
|
SHR-1316 administrated intravenously (IV) at protocol defined dose levels
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The incidence and severity of adverse events/serious adverse events (based on NCI-CTC AE 5.0)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Maximum plasma concentration (Cmax)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Time to maximum concentration (Tmax)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Area under the concentration-time curve from time zero to time(AUC0-t)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Area under the concentration-time curve extrapolated to infinity (AUC0-∞.)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Elimination half-life (t1/2)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Clearance (CL)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Volume of distribution (Vz)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Trough concentration (Cmin)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Accumulatio of ratio (Rac)
Tidsramme: approximately 1 year
|
approximately 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Immunogenicity of SHR-1316
Tidsramme: approximately 1 year
|
Anti-SHR-1316 antibody (ADA), neutralizing antibody (Nab)
|
approximately 1 year
|
Objective response rate (ORR)
Tidsramme: approximately 1 year
|
approximately 1 year
|
|
Progression-free survival (PFS)
Tidsramme: approximately 1 year
|
approximately 1 year
|
|
Duration of response (DoR)
Tidsramme: approximately 1 year
|
approximately 1 year
|
|
Disease control rate (DCR)
Tidsramme: approximately 1 year
|
approximately 1 year
|
|
Overall survival (OS)
Tidsramme: approximately 1 year
|
approximately 1 year
|
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)
10. august 2021
Primær færdiggørelse (Forventet)
10. februar 2022
Studieafslutning (Forventet)
31. juli 2022
Datoer for studieregistrering
Først indsendt
12. juli 2021
Først indsendt, der opfyldte QC-kriterier
16. juli 2021
Først opslået (Faktiske)
28. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SHR-1316-I-103
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
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Sorrento Therapeutics, Inc.Trukket tilbageSolid tumor | Recidiverende solid tumor | Refraktær tumor
-
Memorial Sloan Kettering Cancer CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
-
Baodong QinRekruttering
-
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyRekrutteringSolid tumor, voksen | Refraktær tumorForenede Stater
-
Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Taiwan, Forenede Stater, Australien
-
Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UkendtAvanceret solid tumor eller hæmatologisk tumorKina
-
National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalRekruttering
Kliniske forsøg med SHR-1316
-
Jiangsu HengRui Medicine Co., Ltd.AfsluttetAvancerede maligniteterAustralien, Kina
-
Atridia Pty Ltd.AfsluttetAvancerede maligne tumorerAustralien
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringAvanceret ikke-småcellet lungekræftKina
-
Atridia Pty Ltd.AfsluttetAvancerede solide tumorerAustralien
-
Jiangsu HengRui Medicine Co., Ltd.Ukendt
-
Shandong Suncadia Medicine Co., Ltd.Ikke rekrutterer endnu
-
Jiangsu HengRui Medicine Co., Ltd.AfsluttetSmåcellet lungekræftKina
-
Wuhan Union Hospital, ChinaIkke rekrutterer endnuSmåcellet lungekræft i begrænset stadie, LS-SCLC
-
Tongji HospitalRekruttering
-
Zeng JianRekruttering