Clinical Trials /

CD40 Agonistic Antibody APX005M in Combination With Nivolumab

NCT03123783

Description:

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.

Related Conditions:
  • Melanoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CD40 Agonistic Antibody APX005M in Combination With Nivolumab
  • 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

Clinical Trial IDs

  • ORG STUDY ID: APX005M-002
  • NCT ID: NCT03123783

Conditions

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

Interventions

DrugSynonymsArms
APX005MAPX005M in combination with nivolumab
NivolumabOpdivoAPX005M in combination with nivolumab

Purpose

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
    

Trial Arms

NameTypeDescriptionInterventions
APX005M in combination with nivolumabExperimentalSubjects will receive intravenously APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death.
  • APX005M
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed immunotherapy naïve, metastatic or locally
             advanced non-small cell lung cancer not amenable to curative treatment. Subjects must
             have received one prior platinum based chemotherapy for non-small cell lung cancer
             and subjects with a documented activating mutation (EGFR, ALK or ROS) must also have
             received the appropriate therapy and progressed

          -  Histologically or cytologically confirmed unresectable or metastatic melanoma that
             had 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 anti- CD40, CTLA-4, PD-1/PD-L1 or any other immunomodulatory
             agent (except PD-1/PD-L1 in subjects with metastatic melanoma)

          -  Second malignancy (solid or hematologic) within the past 5 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose limiting toxicities
Time Frame:Up to 21 days following first dose of APX005M and nivolumab
Safety Issue:
Description:Incidence of dose limiting toxicities in Phase 1

Secondary Outcome Measures

Measure:Blood concentrations of APX005M
Time Frame:Predose, end of infusion, 4, 24, 48 and 168 hours following first and third dose of APX005M
Safety Issue:
Description:Blood concentrations of APX005M

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Apexigen, Inc.

Trial Keywords

  • CD40
  • Immunotherapy
  • Nivolumab
  • APX005M
  • PD-1

Last Updated

April 18, 2017