CD40 Agonistic Antibody APX005M in Combination With Nivolumab

• Status: Completed
• Trial end date: 2020-11-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apexigen, Inc.
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Nivolumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, immunotherapy naïve or PD-1/PD-L1 pre-treated, metastatic or locally advanced non-small cell lung cancer not amenable to curative treatment. Subjects may be treatment naive or could have received one prior platinum based chemotherapy for non-small cell lung cancer and subjects with a documented activating mutation (e.g., EGFR, ALK, ROS) must also have received the appropriate therapy and progressed

• Histologically or cytologically confirmed unresectable or metastatic melanoma that had confirmed progressive disease during treatment with anti-PD-1/PD-L1 therapy. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.

• Measurable disease by RECIST 1.1

• ECOG performance status of 0 or 1

• Adequate bone marrow, liver and kidney function

• Negative pregnancy test for women of child bearing potential

• Agreement to use effective methods of contraception per the protocol requirements

Exclusion Criteria:

• Previous exposure to any immunomodulatory agents (e.g., anti- CD40, anti-PD-1/PD-L1, anti-CTLA-4, IDO inhibitors) except PD-1/PD-L1 targeting agents in the subsets of patients that must have previous treatment with anti-PD-1/PD-L1 therapy

• Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured

• Active, known, clinically serious infections within the 14 days prior to first dose of investigational product

• Use of systemic corticosteroids or other systemic immunosuppressive drugs

• Active, known or suspected autoimmune disease

• History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis

• History of interstitial lung disease

• History of life-threatening toxicity related to prior anti-PD-1/PD-L1 treatment for subjects with metastatic melanoma or NSCLC.