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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.

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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

FieldValue
Enrollment Target 140 participants
Start Date 2017-07-10
Est. Completion 2020-11-16
Phase Phase 1

Sponsor

Apexigen America

3 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.