Trials / Completed
CompletedNCT03316144
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Toripalimab | Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry. |
Timeline
- Start date
- 2017-07-12
- Primary completion
- 2018-09-15
- Completion
- 2019-12-30
- First posted
- 2017-10-20
- Last updated
- 2020-09-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03316144. Inclusion in this directory is not an endorsement.