Trials / Completed
CompletedNCT03155425
PD-1 Antibody SHR-1210 in Patients With Relapsed or Refractory Classic Hodgkin's Lymphoma
An Open-Label, Single Arm, Multi-Center, Phase 2 Study of PD-1 Antibody SHR-1210 in Subjects With Relapsed or Refractory Classic Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter, non-randomized, phase 2 trial to evaluate efficacy and safety of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The primary objective is to assess ORR of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma.
Detailed description
The primary objective of this phase 2 study is to assess objective response rate of SHR-1210 in patients with relapsed or refractory classic Hodgkin's lymphoma. The secondary objective is to observe the duration of response, progression free survival, time to response, overall survival and safety of SHR-1210 in relapsed or refractory classic Hodgkin's lymphoma. Pharmacokinetic index is also investigated in 12 patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1210 | A humanized monoclonal immunoglobulin |
Timeline
- Start date
- 2017-06-09
- Primary completion
- 2020-08-31
- Completion
- 2020-09-30
- First posted
- 2017-05-16
- Last updated
- 2024-02-01
- Results posted
- 2024-02-01
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03155425. Inclusion in this directory is not an endorsement.