Trials / Completed
CompletedNCT04068519
Study Investigating Safety, Tolerability, Pharmacokinetics (PK) and Antitumor Activities of Anti-PD-1 (Programmed Death-1) Monoclonal Antibody
Phase I/II Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activities of Anti-PD-1 Monoclonal Antibody BGB-A317 in Chinese Patients With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This was a dose verification, pharmacokinetic (PK) assessment of products derived from two manufacturing processes and scales (500L-FMP and 2000L-FMP; FMP: Final Manufacturing Process) and indication expansion clinical study of monoclonal antibody conducted in Chinese subjects with advanced solid tumors, with a purpose of exploring the safety, tolerability, pharmacokinetics and preliminary efficacy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | Administered intravenously |
Timeline
- Start date
- 2016-12-28
- Primary completion
- 2018-12-01
- Completion
- 2020-05-31
- First posted
- 2019-08-28
- Last updated
- 2024-10-26
- Results posted
- 2023-11-30
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04068519. Inclusion in this directory is not an endorsement.