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Trial record 1 of 1 for:    APX005M-002
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123783
Recruitment Status : Terminated (study completed as planned)
First Posted : April 21, 2017
Last Update Posted : December 14, 2020
Sponsor:
Collaborator:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: N/A
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
Actual Primary Completion Date : November 16, 2020
Actual Study Completion Date : November 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03123783


Locations
Show Show 23 study locations
Sponsors and Collaborators
Apexigen, Inc.
Bristol-Myers Squibb
Investigators
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Study Director: Medical Director Apexigen, Inc.
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Responsible Party: Apexigen, Inc.
ClinicalTrials.gov Identifier: NCT03123783    
Other Study ID Numbers: APX005M-002
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Apexigen, Inc.:
CD40
Immunotherapy
Nivolumab
APX005M
PD-1
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
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
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents