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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of recombinant humanized anti- PD-1 monoclonal antibody(SCT-I10A)in patients with advanced solid tumors or lymphoma treated after failure of standard therapy.
This open label, multicenter phase I study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in advanced solid tumors or lymphoma treated with anti- PD-1 monoclonal antibody SCT-I10A. The trial will be divided into two parts: dose-exploration and indication expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | SCT-I10A will be administered at a dose of 60mg, Q3W up to 24 months. |
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| Middle dose group | Experimental | SCT-I10A will be administered at a dose of 200mg, Q3W up to 24 months. |
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| High dose group | Experimental | SCT-I10A will be administered at a dose of 600mg, Q3W up to 24 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT-I10A | Biological | Experimental: Anti- PD-1 monoclonal antibody(SCT-I10A) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety/Tolerability | Incidence of adverse events and outlier of laboratory tests, positive rate of immunogenicity | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 or Lugano 2014 criteria during trial treatment. | 24 months |
| Duration of response (DOR) |
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Inclusion Criteria:
Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 2.5 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 times ULN; Serum creatinine less than/equal to 1.5 times ULN or Ccr>50ml/min; Thyroid stimulating hormone (TSH) hormone levels less than/equal to ULN.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianming xu, MD | Contact | +8613910866712 | jmxu2003@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
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DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1 or Lugano 2014 criteria, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
| 24 months |
| Disease control rate (DCR) | PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria. | 24 months |
| Progression free survival (PFS) | PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 or Lugano 2014 criteria. | 24 months |
| Overall survival (OS) | OS is defined as time from first dose of SCT200 until the date of death from any cause. | 24 months |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |