MedDataX Logo

Study of the CD40 Agonistic Monoclonal Antibody APX005M

NCT ID: NCT02482168

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

immunotherapy CD40

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

APX005M every 3 week

Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

APX005M every 2 week

Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death.

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

APX005M every 1 week

Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death.

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

APX005M

APX005M is a CD40 agonistic monoclonal antibody

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Apexigen America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Apexigen America, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City of Hope

Duarte, California, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

APX005M-001

Identifier Type: -

Identifier Source: org_study_id