NCT03316144
Completed
Phase 1
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection in Patients With Recurrent Malignant Lymphoma
Shanghai Junshi Bioscience Co., Ltd.1 site in 1 country13 target enrollmentStarted: July 12, 2017Last updated:
ConditionsMalignant Lymphoma
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overview
Brief Summary
The primary objective is to assess the safety and tolerability of JS-001 in subjects with recurrent malignant lymphoma, and to evaluate its preliminary efficacy.
The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing to sign Informed Consent;
- •Re-entry into the study is allowed with a second informed consent;
- •Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
- •A diagnosis of an advanced malignant tumor confirmed by histology or cytology (including typical Hodgkin's lymphoma and B cell source non-hodgkin's lymphoma);
- •No standard of care for the patient;
- •At least 1 measurable lesion;
- •Aged 18-65 years;
- •Anticipated life expectancy of at least 6 months;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •At least 4 weeks elapsed since receiving systemic chemotherapy;
Exclusion Criteria
- •Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- •Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
- •Active, known or suspected autoimmune disease.Autoimmune diseases caused by lymphoma are not included in this list;
- •Patients who have had car-T cell therapy
- •Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
- •Significant medical disease;
- •Active infection;
- •Active tuberculosis or history of tuberculosis with one year;
- •Infection of Human immunodeficiency virus (HIV);
- •A complication requiring immune-suppression;
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 months
Secondary Outcomes
- correlation analysis of PD-L1 expression of tumor(6 months)
- Objective Response Rate (ORR) by irRC and RECIST 1.1(6 months)
Investigators
Study Sites (1)
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