Clinical Trials /

Study of the CD40 Agonistic Monoclonal Antibody APX005M

NCT02482168

Description:

This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT02482168

Trial Eligibility

Document

Title

  • Brief Title: Study of the CD40 Agonistic Monoclonal Antibody APX005M
  • Official Title: Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: APX005M-001
  • NCT ID: NCT02482168

Conditions

  • Cancer
  • NSCLC
  • Melanoma
  • Urothelial Carcinoma
  • MSI-H
  • Head and Neck Cancer

Interventions

DrugSynonymsArms
APX005MAPX005M every 1 week

Purpose

This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.

Detailed Description

      APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8
      dose level cohorts, plus an expansion cohort.

      Eligible subjects with solid tumors will receive intravenous APX005M every 3 week, every 2
      week or every 1 week until disease progression, unacceptable toxicity or death, whichever
      occurs first.

      Study objectives include:

        -  Evaluate safety of APX005M

        -  Determine the maximum tolerated dose of APX005M

        -  Determine the pharmacokinetic parameters of APX005M: the maximal drug concentration
           (Cmax), area under the curve of serum concentration over time (Area Under the Curve/
           AUC), and half-life (t½).

        -  Preliminary assessment of clinical response

Trial Arms

NameTypeDescriptionInterventions
APX005M every 3 weekExperimentalSubjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.
  • APX005M
APX005M every 2 weekExperimentalSubjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death.
  • APX005M
APX005M every 1 weekExperimentalSubjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death.
  • APX005M

Eligibility Criteria

        Key Inclusion Criteria:

          -  Histologically documented diagnosis of solid tumor

          -  For subjects in the every 2 week and every 1 week dosing cohorts histologically or
             cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell
             carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with
             high microsatellite instability status (MSI-high)

          -  No known effective therapy options are available

          -  Measurable disease by RECIST 1.1

          -  ECOG performance status of 0 or 1

          -  Adequate bone marrow, liver and kidney function

          -  No toxicities related to prior treatment related toxicities with the exception of
             alopecia and neuropathy

          -  Negative pregnancy test for women of child bearing potential

        Key Exclusion Criteria:

          -  Any history of or current hematologic malignancy

          -  Major surgery or treatment with any other investigational agent within 4 weeks

          -  Uncontrolled diabetes or hypertension

          -  History of arterial thromboembolic event

          -  History of congestive heart failure, symptomatic ischemia, conduction abnormalities
             uncontrolled by conventional intervention, or myocardial infarction

          -  Active known clinically serious infections
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 28 days following first dose of APX005M
Safety Issue:
Description:The rate of DLTs will be assessed in approximately 56 subjects. DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 3or 4 nausea, cytokine release syndrome and other Grade 3 non-hematological toxicity

Secondary Outcome Measures

Measure:Blood concentrations of APX005M
Time Frame:Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M
Safety Issue:
Description:PK parameters of APX005M
Measure:Presence and titer of anti-APX005M antibodies
Time Frame:Prior to first dose, approximately 3, 6 and 9 weeks following first dose and approximately 4 weeks following last dose of APX005M
Safety Issue:
Description:Assess incidence of anti-drug antibodies (ADA)
Measure:Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame:Every 8 weeks up to approximately 1 year following first dose of APX005M
Safety Issue:
Description:Efficacy assessments will follow RECIST 1.1.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Apexigen, Inc.

Trial Keywords

  • immunotherapy
  • CD40

Last Updated

April 28, 2020