Study of the CD40 Agonistic Monoclonal Antibody APX005M

• Sponsor: Apexigen, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02482168
• Collaborator: (none)
• Enrollment: 43
• Locations: 3
• Arms: 3
• Duration (Months): 37.6
• Patients Per Site: 14.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; NSCLC; Melanoma; Urothelial Carcinoma; MSI-H; Head and Neck Cancer	Drug: APX005M	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 13, 2018
• Actual Study Completion Date: Jun 19, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of dose limiting toxicities [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

2. Incidence of adverse events [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

Secondary Outcome Measures

1. Blood concentrations of APX005M [Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M]

   PK parameters of APX005M

2. 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]

   Assess incidence of anti-drug antibodies (ADA)

3. 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]

   Efficacy assessments will follow RECIST 1.1.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	Case Western Reserve University	Cleveland	Ohio	United States	44106
3	Abramson Cancer Center of The University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Apexigen, Inc.

Investigators

• Study Director: Medical Director, Apexigen, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apexigen, Inc.
• ClinicalTrials.gov Identifier: NCT02482168
• Other Study ID Numbers: APX005M-001
• First Posted: Jun 26, 2015
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2018

• Keywords provided by Apexigen, Inc.: immunotherapy; CD40
• Additional relevant MeSH terms: Head and Neck Neoplasms; Carcinoma, Transitional Cell

Study Results

No Results Posted as of Apr 28, 2020