Trials / Completed
CompletedNCT04177290
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sintilimab (M1b) | Intravenous infusion |
| DRUG | Sintilimab (approved) | Intravenous infusion |
Timeline
- Start date
- 2020-04-02
- Primary completion
- 2021-02-28
- Completion
- 2022-09-04
- First posted
- 2019-11-26
- Last updated
- 2023-02-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04177290. Inclusion in this directory is not an endorsement.