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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03123783
Study type Interventional
Source Apexigen America, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 10, 2017
Completion date November 16, 2020

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