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
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.
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of dose limiting toxicities
Secondary Outcome
Blood concentrations of APX005M
Condition
Cancer
Intervention
APX005M
Study Arms / Comparison Groups
APX005M every 3 week
Description: Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
43
Start Date
May 2015
Completion Date
June 19, 2018
Primary Completion Date
June 13, 2018
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02482168
Organization ID
APX005M-001
Responsible Party
Sponsor
Study Sponsor
Apexigen, Inc.
Study Sponsor
Medical Director, Study Director, Apexigen, Inc.
Verification Date
April 2018