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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | 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 | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | PK parameters of single dose of SHR-2002 injection monotherapy | 0.5 hour before first dose to the 336 hours after first dose |
| Cmax | PK parameters of single dose of SHR-2002 injection monotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Science and Technology University First Affiliated Hospital | Luoyang | Henan | 471003 | China | ||
| Hunan Cancer Hospital |
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SHR-2002 injection monotherapy and in combination with other anti-cancer therapy
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|
| 0.5 hour before first dose to the 336 hours after first dose |
| AUC0-t | PK parameters of single dose of SHR-2002 injection monotherapy | 0.5 hour before first dose to the 336 hours after first dose |
| AUC0-∞ | 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 | PK parameters of single dose of SHR-2002 injection monotherapy | 0.5 hour before first dose to the 336 hours after first dose |
| CL | PK parameters of single dose of SHR-2002 injection monotherapy | 0.5 hour before first dose to the 336 hours after first dose |
| Vss | 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 | PK parameters of multiple doses of SHR-2002 monotherapy | 0.5 hour before second dose to the 30 days after last dose |
| Ctrough, ss | PK parameters of multiple doses of SHR-2002 monotherapy | 0.5 hour before second dose to the 30 days after last dose |
| Rac | PK parameters of multiple doses of SHR-2002 monotherapy | 0.5 hour before second dose to the 30 days after last dose |
| RO | Receptor occupancy, PD indicators of SHR-2002 injection monotherapy | 0.5 hour before second dose to the 30 days after last dose |
| Cytokine concentration | PD indicators of SHR-2002 injection monotherapy | 0.5 hour before second dose to the 30 days after last dose |
| Ctrough, ss | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Changsha |
| Hunan |
| 410006 |
| China |
| Linyi Cancer Hospital | Linyi | Shandong | 276002 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 410013 | China |
| ID | Term |
|---|---|
| D007267 | Injections |
| C000723862 | SHR-1701 |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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