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NCT03474640 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
A Phase 1 study, sponsored by TopAlliance Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 184
- Enrollment target
NCT03474640: Completed Phase 1 study, sponsored by TopAlliance Biosciences.
NCT03474640 is a Phase 1 study that has completed, run by TopAlliance Biosciences. The registered enrollment target is 184 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (207% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03474640, a Phase 1 study, has completed, sponsored by TopAlliance Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 184 participants
- Enrollment target
Study Summary
The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of Toripalimab, 2) evaluate antitumor activity of Toripalimab; 3) determine the immunogenicity of Toripalimab; 4) evaluate overall survival. The exploratory objectives are to: 1) evaluate biomarkers that may correlate with activity of Toripalimab, 2) evaluate pharmacodynamic effects of Toripalimab on its target receptor, programmed cell death 1 (PD-1), as well as effects on the immune system. 3) evaluate the utility of PD-L1 \& additional exploratory markers as biomarkers that could aid in selection of appropriate subjects for TAB001 therapy, and 4) identification of additional biomarkers correlating with response to treatment with TAB001.
Primary Outcome
To assess the number of treatment-related adverse events in the toripalimab arm as assessed by CTCAE v4.0
Interventions
- BIOLOGICAL Part A
- BIOLOGICAL Part B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2022-07-07 |
| Phase | Phase 1 |
What the finished NCT03474640 record still lists
NCT03474640 is an interventional study that assigns participants to a tested intervention. The registered 184 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (207% higher).
The record links to 0 conditions, and to 2 interventions - of which Part A is the first listed.
NCT03474640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03474640 about?
NCT03474640 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies". The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of Toripalimab, 2) evaluate antitumor activity of ...
What is the current status of trial NCT03474640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 184 participants. The study started on 2018-02-21. Estimated completion is 2022-07-07.
What interventions are being tested in trial NCT03474640?
The interventions under investigation include: Part A (BIOLOGICAL), Part B (BIOLOGICAL).
Who is sponsoring clinical trial NCT03474640?
This trial is sponsored by TopAlliance Biosciences, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03474640's enrollment target sits among peer trials
184 294th of 2000 higher than 1,704 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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