Study of the CD40 Agonistic Monoclonal Antibody APX005M
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ClinicalTrials.gov Identifier: NCT02482168 |
Recruitment Status :
Completed
First Posted : June 26, 2015
Last Update Posted : April 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Cancer NSCLC Melanoma Urothelial Carcinoma MSI-H Head and Neck Cancer | Drug: APX005M | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
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 2015 |
Actual Primary Completion Date : | June 13, 2018 |
Actual Study Completion Date : | June 19, 2018 |

Arm | Intervention/treatment |
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Experimental: APX005M every 3 week
Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.
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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.
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Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody |
- Incidence of dose limiting toxicities [ Time Frame: 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
- Incidence of adverse events [ Time Frame: 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
- Blood concentrations of APX005M [ Time Frame: Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M ]PK parameters of APX005M
- Presence and titer of anti-APX005M antibodies [ Time Frame: 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)
- Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 8 weeks up to approximately 1 year following first dose of APX005M ]Efficacy assessments will follow RECIST 1.1.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482168
United States, California | |
City of Hope | |
Duarte, California, United States, 91010 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Abramson Cancer Center of The University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Director: | Medical Director | Apexigen, Inc. |
Responsible Party: | Apexigen, Inc. |
ClinicalTrials.gov Identifier: | NCT02482168 |
Other Study ID Numbers: |
APX005M-001 |
First Posted: | June 26, 2015 Key Record Dates |
Last Update Posted: | April 28, 2020 |
Last Verified: | April 2018 |
immunotherapy CD40 |
Head and Neck Neoplasms Carcinoma, Transitional Cell Neoplasms by Histologic Type Neoplasms |
Neoplasms by Site Carcinoma Neoplasms, Glandular and Epithelial |