CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Completed · Phase 1/Phase 2

Conditions studied: Cancer, Non Small Cell Lung Cancer Metastatic, Metastatic Melanoma, Neoplasm of Lung, Melanoma

In brief

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.

Key facts

Study ID

NCT03123783

Run by

Apexigen America, Inc.

People needed

140

Starts

2017-07-10

Expected to finish

2020-11-16

Last updated by the study team

2023-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 progressed during treatment with an anti-PD-1/PD-L1 therapy and had confirmation of PD>=4 weeks later. 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

You may not qualify if…

• 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.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• Yale University — New Haven, Connecticut, United States
• Hem-Onc Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) — Baltimore, Maryland, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• SUNY Upstate Medical Hospital — Syracuse, New York, United States
• University Hospitals Seidman Cancer Center — Cleveland, Ohio, United States
• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Fox Chase Center — Rockledge, Pennsylvania, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Hospital Quirón Dexeus — Barcelona, Spain
• H. Vall d'Hebron — Barcelona, Spain
• H. Clinic i Provincial — Barcelona, Spain
• H. Insular de Gran Canaria — Las Palmas de Gran Canaria, Spain
• H. Lucus Augusti — Lugo, Spain
• H. Doce de Octubre — Madrid, Spain
• H. HM Sanchinnarro — Madrid, Spain
• H. de Málaga — Málaga, Spain
• H. La Fe — Valencia, Spain
• H. General de Valencia — Valencia de Alcántara, Spain

Full record on ClinicalTrials.gov

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