- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05198817
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
26 juni 2022 uppdaterad av: 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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
240
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Henan
-
Luoyang, Henan, Kina, 471003
- Henan Science and Technology University First Affiliated Hospital
-
-
Hunan
-
Changsha, Hunan, Kina, 410006
- Hunan Cancer hospital
-
-
Shandong
-
Linyi, Shandong, Kina, 276002
- Linyi Cancer Hospital
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200433
- Shanghai Pulmonary Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 410013
- West China Hospital of Sichuan University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Enskild grupp
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Maximum tolerated dose
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Tmax
Tidsram: 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
Tidsram: 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
Tidsram: 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-∞
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
22 februari 2022
Primärt slutförande (Förväntat)
31 januari 2023
Avslutad studie (Förväntat)
30 juni 2023
Studieregistreringsdatum
Först inskickad
3 januari 2022
Först inskickad som uppfyllde QC-kriterierna
17 januari 2022
Första postat (Faktisk)
20 januari 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SHR-2002-I-101
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Obeslutsam
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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Nej
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