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Study of the CD40 Agonistic Monoclonal Antibody APX005M

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ClinicalTrials.gov Identifier: NCT02482168
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Apexigen, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer NSCLC Melanoma Urothelial Carcinoma MSI-H Head and Neck Cancer Drug: APX005M Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors
Study Start Date : May 2015
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: APX005M every 3 week
Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody

Experimental: APX005M every 2 week
Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death.
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody

Experimental: APX005M every 1 week
Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death.
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody




Primary Outcome Measures :
  1. Incidence of dose limiting toxicities [ Time Frame: Up to 28 days following first dose of APX005M ]
    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

  2. Incidence of adverse events [ Time Frame: Through up to approximately 4 weeks following last dose of APX005M ]
    Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v4.03


Secondary Outcome Measures :
  1. Blood concentrations of APX005M [ Time Frame: Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M ]
    PK parameters of APX005M

  2. 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 ]
    Assess incidence of anti-drug antibodies (ADA)

  3. 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 ]
    Efficacy assessments will follow RECIST 1.1.



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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

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

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): NCT02482168


Locations
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United States, California
City of Hope
Duarte, California, United States, 91010
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Apexigen, Inc.
Investigators
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Study Director: Medical Director Apexigen, Inc.
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Responsible Party: Apexigen, Inc.
ClinicalTrials.gov Identifier: NCT02482168    
Other Study ID Numbers: APX005M-001
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2018
Keywords provided by Apexigen, Inc.:
immunotherapy
CD40
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Carcinoma, Transitional Cell
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Carcinoma
Neoplasms, Glandular and Epithelial