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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 is a Phase 1 study that has completed, run by TopAlliance Biosciences. The registered enrollment target is 184 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03474640
The ClinicalTrials.gov registry entry for NCT03474640 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 184 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TopAlliance Biosciences, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Part A is the first listed.
NCT03474640 reports 0 study locations.
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.
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