- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05198817
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
26 giugno 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Iscrizione su invito
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Anticipato)
240
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Henan
-
Luoyang, Henan, Cina, 471003
- Henan Science and Technology University First Affiliated Hospital
-
-
Hunan
-
Changsha, Hunan, Cina, 410006
- Hunan Cancer Hospital
-
-
Shandong
-
Linyi, Shandong, Cina, 276002
- Linyi Cancer Hospital
-
-
Shanghai
-
Shanghai, Shanghai, Cina, 200433
- Shanghai Pulmonary Hospital
-
-
Sichuan
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Chengdu, Sichuan, Cina, 410013
- West China Hospital of Sichuan University
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Singolo Gruppo
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum tolerated dose
Lasso di tempo: first dose of study medication up to 21 days
|
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
Lasso di tempo: first dose of study medication up to 21 days
|
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)
Lasso di tempo: 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
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tmax
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
Cmax
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
AUC0-t
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
AUC0-∞
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
t1/2
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
CL
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
Vss
Lasso di tempo: 0.5 hour before first dose to the 336 hours after first dose
|
PK parameters of single dose of SHR-2002 injection monotherapy
|
0.5 hour before first dose to the 336 hours after first dose
|
|
Cmax, ss
Lasso di tempo: 0.5 hour before second dose to the 30 days after last dose
|
PK parameters of multiple doses of SHR-2002 monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
|
Ctrough, ss
Lasso di tempo: 0.5 hour before second dose to the 30 days after last dose
|
PK parameters of multiple doses of SHR-2002 monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
|
Rac
Lasso di tempo: 0.5 hour before second dose to the 30 days after last dose
|
PK parameters of multiple doses of SHR-2002 monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
|
RO
Lasso di tempo: 0.5 hour before second dose to the 30 days after last dose
|
Receptor occupancy, PD indicators of SHR-2002 injection monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
|
Cytokine concentration
Lasso di tempo: 0.5 hour before second dose to the 30 days after last dose
|
PD indicators of SHR-2002 injection monotherapy
|
0.5 hour before second dose to the 30 days after last dose
|
|
Ctrough, ss
Lasso di tempo: 0.5 hour before second dose to the 90 days after last dose
|
PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
|
0.5 hour before second dose to the 90 days after last dose
|
|
Rac
Lasso di tempo: 0.5 hour before second dose to the 90 days after last dose
|
PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period
|
0.5 hour before second dose to the 90 days after last dose
|
|
ADA
Lasso di tempo: 0.5 hour before second dose to the 90 days after last dose
|
Anti-drug antibody, Immunogenicity of SHR-2002 in monotherapy and combination therapy, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
|
0.5 hour before second dose to the 90 days after last dose
|
|
NAb
Lasso di tempo: 0.5 hour before second dose to the 90 days after last dose
|
Immunogenicity of Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection
|
0.5 hour before second dose to the 90 days after last dose
|
|
ORR
Lasso di tempo: 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]
|
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
|
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]
|
|
DoR
Lasso di tempo: 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
|
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
|
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
|
|
DCR
Lasso di tempo: 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
|
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
|
|
PFS
Lasso di tempo: 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
|
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
|
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
|
|
OS
Lasso di tempo: from the date of the first dose to the date of death for any reason,assessed up to 100 months
|
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
|
from the date of the first dose to the date of death for any reason,assessed up to 100 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
22 febbraio 2022
Completamento primario (Anticipato)
31 gennaio 2023
Completamento dello studio (Anticipato)
30 giugno 2023
Date di iscrizione allo studio
Primo inviato
3 gennaio 2022
Primo inviato che soddisfa i criteri di controllo qualità
17 gennaio 2022
Primo Inserito (Effettivo)
20 gennaio 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 giugno 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 giugno 2022
Ultimo verificato
1 giugno 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SHR-2002-I-101
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Indeciso
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .