Study of the CD40 Agonistic Monoclonal Antibody APX005M

NCT02482168 | Completed Phase 1

• 1 other identifier: APX005M-001
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

immunotherapy; CD40

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicities

  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

  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 Outcomes (3)

• Blood concentrations 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

  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)

  Every 8 weeks up to approximately 1 year following first dose of APX005M

Study Arms (3)

APX005M every 3 week

EXPERIMENTAL

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

Drug: APX005M

APX005M every 2 week

EXPERIMENTAL

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

Drug: APX005M

APX005M every 1 week

EXPERIMENTAL

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

Drug: APX005M

Interventions

APX005M DRUG

APX005M is a CD40 agonistic monoclonal antibody

APX005M every 1 week; APX005M every 2 week; APX005M every 3 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apexigen America, Inc.: lead

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma; Carcinoma, Transitional Cell; Head and Neck Neoplasms

Interventions

sotigalimab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Medical Director

  Apexigen America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 26, 2015
• Study Start: May 1, 2015
• Primary Completion: June 13, 2018
• Study Completion: June 19, 2018
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

US (3)