CD40 Agonistic Antibody APX005M in Combination With Nivolumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03123783
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : November 7, 2018
Bristol-Myers Squibb
Information provided by (Responsible Party):
Apexigen, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Non Small Cell Lung Cancer Metastatic Metastatic Melanoma Neoplasm of Lung Melanoma Drug: APX005M Drug: Nivolumab Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: APX005M in combination with nivolumab
Subjects will receive intravenously APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death.
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody

Drug: Nivolumab
Nivolumab is an immune checkpoint (PD-1) blocking antibody
Other Name: Opdivo

Primary Outcome Measures :
  1. Incidence of dose limiting toxicities [ Time Frame: Up to 21 days following first dose of APX005M and nivolumab ]
    Incidence of dose limiting toxicities in Phase 1

  2. Incidence of adverse events [ Time Frame: Through up to approximately 4 weeks following last dose of APX005M and/or nivolumab ]
    Incidence of adverse events throughout the study

  3. Objective response rate [ Time Frame: Every 8 weeks up to approximately 1 year following first dose of APX005M and nivolumab ]
    Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary Outcome Measures :
  1. Blood concentrations of APX005M [ Time Frame: Predose, end of infusion, 4, 24, 48 and 168 hours following first and third dose of APX005M ]
    Blood concentrations of APX005M

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed immunotherapy naïve, 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, CTLA-4, PD-1/PD-L1, IDO inhibitors) or any other immunomodulatory agent (with the following (except PD-1/PD-L1 in subjects with unresectable or metastatic melanoma)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03123783

Contact: Apexigen, Inc. 650.931.6236

United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Kerry-Ann Suckra    520-626-0375   
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Thomas Fok   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Liz Perrotti    203-815-4124   
United States, Florida
Hem-Onc Associates of the Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 32952
Contact: Christine Gerdes, RN, OCN, CCRP    772-408-5159   
United States, Georgia
University Cancer & Blood Center Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie M Hodgson    706-353-2990 ext 279   
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Megan Meays, CCRC    402-691-6971   
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Carberry    215-614-1813   
Contact: Lydia Giles    215-662-6389   
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Linda Thibodeau   
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Misty Moore   
Sponsors and Collaborators
Apexigen, Inc.
Bristol-Myers Squibb
Study Director: Medical Director Apexigen, Inc.

Responsible Party: Apexigen, Inc. Identifier: NCT03123783     History of Changes
Other Study ID Numbers: APX005M-002
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Apexigen, Inc.:

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents