NCT03123783

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Apexigen America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Cancer
• Non Small Cell Lung Cancer Metastatic
• Metastatic Melanoma
• Neoplasm of Lung
• Melanoma

Interventions

Type	Name	Description
DRUG	APX005M	APX005M is a CD40 agonistic monoclonal antibody
DRUG	Nivolumab	Nivolumab is an immune checkpoint (PD-1) blocking antibody

Timeline

• Start date: 2017-07-10
• Primary completion: 2020-11-16
• Completion: 2020-11-16
• First posted: 2017-04-21
• Last updated: 2023-12-26
• Results posted: 2023-12-05

Locations

23 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study