CancerPhase 1NCT02482168
Study of the CD40 Agonistic Monoclonal Antibody APX005M
A Phase 1 study testing APX005M in people with Cancer and NSCLC, run by Apexigen America, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- APX005M
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2015to 19 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case Western Reserve University
Cleveland, Ohio, 44106
City of Hope
Duarte, California, 91010
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors
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.
Read the 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
- Conditions
- Cancer, NSCLC, Melanoma, Urothelial Carcinoma, MSI-H, Head and Neck Cancer
- Being tested
- APX005M
- Keywords
- immunotherapy, CD40
- Medical subject headings
- Neoplasms, Melanoma, Carcinoma, Transitional Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APX005MDrug
APX005M is a CD40 agonistic monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| APX005M every 3 week | Experimental | Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death. Receives: Drug: APX005M |
| APX005M every 2 week | Experimental | Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death. Receives: Drug: APX005M |
| APX005M every 1 week | Experimental | Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death. Receives: Drug: APX005M |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through up to approximately 4 weeks following last dose of APX005M
Secondary outcomes (3)
Blood concentrations of APX005M
PK parameters of APX005M
Measured: 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
Assess incidence of anti-drug antibodies (ADA)
Measured: 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)
Efficacy assessments will follow RECIST 1.1.
Measured: Every 8 weeks up to approximately 1 year following first dose of APX005M
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion13 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apexigen America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Apexigen America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482168
- Sponsor's protocol ID
- APX005M-001
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2015
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT02482168
- Acronym / sponsor ID
- APX005M-001
- Conditions
- Cancer, NSCLC, Melanoma, Urothelial Carcinoma, MSI-H, Head and Neck Cancer
- Keywords
- immunotherapy, CD40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Apexigen America, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APX005M every 3 week | Experimental | Drug: APX005MSubjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death. |
| APX005M every 2 week | Experimental | Drug: APX005MSubjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death. |
| APX005M every 1 week | Experimental | Drug: APX005MSubjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APX005MAPX005M is a CD40 agonistic monoclonal antibody | Drug | APX005M every 1 week, APX005M every 2 week, APX005M every 3 week |
Primary outcome
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
3 secondary outcomes
Blood concentrations of APX005M
Time frame: 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
Time frame: 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)
Time frame: Every 8 weeks up to approximately 1 year following first dose of APX005M
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Apexigen America, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APX005M in people with Cancer and NSCLC, run by Apexigen America, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (time frame: Up to 28 days following first dose of APX005M). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.