- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05198817
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
26. června 2022 aktualizováno: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients.
To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.
Přehled studie
Postavení
Zápis na pozvánku
Podmínky
Typ studie
Intervenční
Zápis (Očekávaný)
240
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Henan
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Luoyang, Henan, Čína, 471003
- Henan Science and Technology University First Affiliated Hospital
-
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Hunan
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Changsha, Hunan, Čína, 410006
- Hunan Cancer Hospital
-
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Shandong
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Linyi, Shandong, Čína, 276002
- Linyi Cancer Hospital
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Shanghai
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Shanghai, Shanghai, Čína, 200433
- Shanghai Pulmonary Hospital
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Sichuan
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Chengdu, Sichuan, Čína, 410013
- West China Hospital of Sichuan University
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
- Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
- Histopathologically or cytologically documented advanced or metastatic malignancies;
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- Life expectancy ≥12 weeks;
- Adequate organ functions as defined;
- Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.
Exclusion Criteria:
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
- Patients with tumor-related pain that cannot be controlled as determined by the investigator;
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
- Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
- Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
- Patients who have received >30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
- Unresolved CTCAE Grade >1 toxicity attributed to any prior anti-tumor therapy;
- Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
- Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
- Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
- History of autoimmune diseases;
- History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
- History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
- Evidence or history of arterial/venous thrombosis within 3 months before the first dose;
- Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment;
- Known history of serious allergic reactions to the investigational product or its main ingredients;
- History of immunodeficiency;
- Presence of active hepatitis B or active hepatitis C;
- Severe infections within 4 weeks prior to the first study treatment;
- Evidence or history of active pulmonary tuberculosis within 1 year before study entry;
- any other conditions that are not suitable for participation in the study in the investigator's opinion.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Jedna skupina
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Firstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted.
After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximum tolerated dose
Časové okno: first dose of study medication up to 21 days
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The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
|
first dose of study medication up to 21 days
|
|
Recommended phase II dose
Časové okno: first dose of study medication up to 21 days
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The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
|
first dose of study medication up to 21 days
|
|
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Časové okno: from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
|
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Tmax
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
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0.5 hour before first dose to the 336 hours after first dose
|
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Cmax
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
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PK parameters of single dose of SHR-2002 injection monotherapy
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0.5 hour before first dose to the 336 hours after first dose
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AUC0-t
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
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PK parameters of single dose of SHR-2002 injection monotherapy
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0.5 hour before first dose to the 336 hours after first dose
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AUC0-∞
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
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PK parameters of single dose of SHR-2002 injection monotherapy
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0.5 hour before first dose to the 336 hours after first dose
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t1/2
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
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PK parameters of single dose of SHR-2002 injection monotherapy
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0.5 hour before first dose to the 336 hours after first dose
|
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CL
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
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PK parameters of single dose of SHR-2002 injection monotherapy
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0.5 hour before first dose to the 336 hours after first dose
|
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Vss
Časové okno: 0.5 hour before first dose to the 336 hours after first dose
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PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
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Cmax, ss
Časové okno: 0.5 hour before second dose to the 30 days after last dose
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PK parameters of multiple doses of SHR-2002 monotherapy
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0.5 hour before second dose to the 30 days after last dose
|
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Ctrough, ss
Časové okno: 0.5 hour before second dose to the 30 days after last dose
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PK parameters of multiple doses of SHR-2002 monotherapy
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0.5 hour before second dose to the 30 days after last dose
|
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Rac
Časové okno: 0.5 hour before second dose to the 30 days after last dose
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PK parameters of multiple doses of SHR-2002 monotherapy
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0.5 hour before second dose to the 30 days after last dose
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RO
Časové okno: 0.5 hour before second dose to the 30 days after last dose
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Receptor occupancy, PD indicators of SHR-2002 injection monotherapy
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0.5 hour before second dose to the 30 days after last dose
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Cytokine concentration
Časové okno: 0.5 hour before second dose to the 30 days after last dose
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PD indicators of SHR-2002 injection monotherapy
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0.5 hour before second dose to the 30 days after last dose
|
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Ctrough, ss
Časové okno: 0.5 hour before second dose to the 90 days after last dose
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PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
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0.5 hour before second dose to the 90 days after last dose
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Rac
Časové okno: 0.5 hour before second dose to the 90 days after last dose
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PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
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0.5 hour before second dose to the 90 days after last dose
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ADA
Časové okno: 0.5 hour before second dose to the 90 days after last dose
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Anti-drug antibody, Immunogenicity of SHR-2002 in monotherapy and combination therapy, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
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0.5 hour before second dose to the 90 days after last dose
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NAb
Časové okno: 0.5 hour before second dose to the 90 days after last dose
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Immunogenicity of Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
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0.5 hour before second dose to the 90 days after last dose
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ORR
Časové okno: from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]
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Objective Response Rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months]
|
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DoR
Časové okno: from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months
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Duration of response, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months
|
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DCR
Časové okno: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
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Disease control rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
|
from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
|
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PFS
Časové okno: from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
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Progression-free survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months
|
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OS
Časové okno: from the date of the first dose to the date of death for any reason,assessed up to 100 months
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Overall survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors
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from the date of the first dose to the date of death for any reason,assessed up to 100 months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
22. února 2022
Primární dokončení (Očekávaný)
31. ledna 2023
Dokončení studie (Očekávaný)
30. června 2023
Termíny zápisu do studia
První předloženo
3. ledna 2022
První předloženo, které splnilo kritéria kontroly kvality
17. ledna 2022
První zveřejněno (Aktuální)
20. ledna 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
28. června 2022
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. června 2022
Naposledy ověřeno
1. června 2022
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SHR-2002-I-101
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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