Last updated on May 2019

CD40 Agonistic Antibody APX005M in Combination With Nivolumab


Brief description of study

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.

Detailed Study Description

APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion (Phase

  1. followed by a Phase 2 tumor specific portion.

Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death, whichever occurs first.

Study objectives include:

  • Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when given in combination with nivolumab
  • Evaluate safety of the APX005M and nivolumab combination
  • Evaluate the objective response rate, duration of response and median PFS by RECIST 1.1 in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in combination with nivolumab
  • Determine the PK of APX005M

Clinical Study Identifier: NCT03123783

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University Hospitals Seidman Cancer Center

Cleveland, OH United States
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