Study of the CD40 Agonistic Monoclonal Antibody APX005M

December 19, 2023 updated by: Apexigen America, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 28 days following first dose of APX005M
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
Through up to approximately 4 weeks following last dose of APX005M

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M
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)
Prior to first dose, approximately 3, 6 and 9 weeks following first dose and approximately 4 weeks following last dose of APX005M
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.
Every 8 weeks up to approximately 1 year following first dose of APX005M

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apexigen America, Inc.

Investigators

  • Study Director: Medical Director, Apexigen America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

June 13, 2018

Study Completion (Actual)

June 19, 2018

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimated)

June 26, 2015

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APX005M-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe