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

APX005M-001

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.

2015-05-01

2018-06-13

2018-06-19

Completed

Early phase I

43

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

2023-12-20