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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: Completed Phase 1 study, sponsored by Apexigen America.
NCT03123783 is a Phase 1 study that has completed, run by Apexigen America. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
All toxicities were graded according to the NCI-CTCAE version 4.03. DLT was defined as any of the following events attributed to APX005M and nivolumab combination: * Grade 4 hematologic toxicity lasting ≥ 7 days (except asymptomatic lymphopenia) * Grade 3 or 4 neutropenia with a single temperature of \>38.3◦ C (101◦ F) or a sustained temperature of ≥38◦ C (100.4◦ F) for more than one hour * Grade 4 thrombocytopenia or Grade ≥3 thrombocytopenia with signs or symptoms of bleeding or requiring pla
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 |
What the finished NCT03123783 record still lists
NCT03123783 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (133% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03123783 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03123783's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 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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