- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198817
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
June 26, 2022 updated by: 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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471003
- Henan Science and Technology University First Affiliated Hospital
-
-
Hunan
-
Changsha, Hunan, China, 410006
- Hunan Cancer Hospital
-
-
Shandong
-
Linyi, Shandong, China, 276002
- LinYi Cancer Hospital
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Shanghai Pulmonary Hospital
-
-
Sichuan
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Chengdu, Sichuan, China, 410013
- West China Hospital of Sichuan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose
Time Frame: 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
Time Frame: 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)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: 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
Time Frame: 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
Time Frame: 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-∞
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 0.5 hour before second dose to the 30 days after last dose
|
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
|
Rac
Time Frame: 0.5 hour before second dose to the 30 days after last dose
|
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
Time Frame: 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
Time Frame: 0.5 hour before second dose to the 30 days after last dose
|
PD indicators of SHR-2002 injection monotherapy
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0.5 hour before second dose to the 30 days after last dose
|
Ctrough, ss
Time Frame: 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
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0.5 hour before second dose to the 90 days after last dose
|
Rac
Time Frame: 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
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0.5 hour before second dose to the 90 days after last dose
|
ADA
Time Frame: 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
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0.5 hour before second dose to the 90 days after last dose
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NAb
Time Frame: 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
|
0.5 hour before second dose to the 90 days after last dose
|
ORR
Time Frame: 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
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
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
Time Frame: 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
|
from the date of the first dose to the date of death for any reason,assessed up to 100 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2022
Primary Completion (Anticipated)
January 31, 2023
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
January 3, 2022
First Submitted That Met QC Criteria
January 17, 2022
First Posted (Actual)
January 20, 2022
Study Record Updates
Last Update Posted (Actual)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 26, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-2002-I-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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