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NCT03123783 · ClinicalTrials.gov registry record · Phase 1
CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
A Phase 1 study, sponsored by Apexigen America.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT03123783 is a Phase 1 study that has completed, run by Apexigen America. The registered enrollment target is 140 participants.
The verdict
NCT03123783, a Phase 1 study, has completed, sponsored by Apexigen America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.
Interventions
- DRUG Nivolumab
- DRUG APX005M
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2020-11-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03123783
The ClinicalTrials.gov registry entry for NCT03123783 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Apexigen America, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03123783 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03123783 about?
NCT03123783 is a clinical study titled "CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab". This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose...
What is the current status of trial NCT03123783?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2017-07-10. Estimated completion is 2020-11-16.
What interventions are being tested in trial NCT03123783?
The interventions under investigation include: Nivolumab (DRUG), APX005M (DRUG).
Who is sponsoring clinical trial NCT03123783?
This trial is sponsored by Apexigen America, which has 3 total clinical trials registered on ClinicalTrials.gov.
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