Solid TumorsPhase 1NCT01313065
Evaluation of Safety, Tolerability, PK & PD of Intravenous VX15/2503 in Patients With Advanced Solid Tumors
A Phase 1 study testing VX15/2503 in people with Solid Tumors, run by Vaccinex Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with advanced solid tumors. The escalation part of the study will determine the maximum tolerated dose (MTD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- VX15/2503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Jun 2014
- 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
Main Inclusion Criteria:
- Patients 18 yrs or older with confirmed histological or cytological advanced solid tumors, relapsed or refractory to standard treatment for which no curative therapy is available; patients must demonstrate progressive disease prior to entry
- Has measurable disease as defined by RECIST1.1
- Life expectancy of at least 3 months (per investigator assessment)
- ECOG performance status of 0-2
- Adequate bone marrow, renal and liver function
- Recovered from any significant prior toxicity of previous anti-neoplastic therapy
- For patients of reproductive potential, is willing to use a medically acceptable form of contraception throughout the study period and for at least 4 weeks after the last dose of VX15/2503
- Expansion cohort - patients in this cohort must have one of the following characteristics:
- A diagnosis of a pancreatic neuroendocrine tumor OR
- A diagnosis of a soft tissue sarcoma OR
- A diagnosis of a bone metastasis OR
- A diagnosis of advanced solid tumor AND a T cell count of at least 1500 cells/uL OR a B cell count of at least 250 cells/uL at screening
Main Exclusion Criteria:
- Treatment with anti-neoplastic agents (chemotherapy, immunotherapy, radiotherapy or endocrine therapy) within 3 weeks prior to start of study treatment
- Treatment with an investigational agent within 4 weeks prior to start of study treatment
- Is on concurrent anti-neoplastic therapy with the exception of continuing luteinizing hormone-releasing hormone agonist/antagonist therapy for patients with castrate-resistant prostate cancer
- Treatment with oral or parenteral corticosteroids in excess of 10mg/day of prednisolone or equivalent for more than 5 days within 4 weeks prior to start of study treatment or a requirement for systemic immunosuppressive therapy for any reason
- Untreated brain Mets or CNS tumor involvement
- Any other intercurrent illness or condition which could impact patient compliance or ability to complete the study
- Sensitivity to VX15/2503 or the ingredients or excipients of VX15/2503
- Pregnant or breast-feeding women (women of child-bearing potential must have negative serum pregnancy test within 3 days prior to receiving the first dose of VX15/2503)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
Virginia G. Piper Cancer Center at Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
Official title: A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of VX15/2503 in Adult Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with advanced solid tumors. The escalation part of the study will determine the maximum tolerated dose (MTD).
Read the detailed description
VX15/2503-01 is a dose-escalation, open label study to evaluate the safety and tolerability of IV administered VX15/2503 in patients with advanced solid tumors. This will be accomplished by using a dose escalation procedure starting at low doses of VX15/2503 and will continue based on predefined parameters until the maximum tolerated dose is identified.
The study drug, VX15/2503, is a monoclonal antibody that binds to the semaphorin 4D (SEMA4D; CD100) antigen. Semaphorins have been shown to play an important role in certain physiological processes such as vascular growth, tumor progression and immune cell regulation. Experimental evidence suggests that SEMA4D has two mechanisms of action that result in angiogenesis and tumor proliferation and invasion. Antibody neutralization of SEMA4D thus may represent a new therapeutic strategy for cancer treatment.
- Conditions
- Solid Tumors
- Being tested
- VX15/2503
- Keywords
- VX15/2503, Semaphorin 4D, SEMA4D, CD100, safety, tolerability, pharmacokinetics, pharmacodynamics, advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX15/2503Drug
Dose escalation will begin at low doses and will gradually increase in each future cohort. The current trial design provides for 7 study cohorts with a 20 mg/kg expansion phase.
| Study group | Role | What they receive |
|---|---|---|
| VX15/2503 | Experimental | VX15/2503 monoclonal antibody at a concentration of 0.3 mg/kg - 20 mg/kg to be administered intravenously on a weekly dosing cycle. Receives: Drug: VX15/2503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability as measured by number of patients with adverse events
Subject incidence of treatment-emergent adverse events
Measured: Up to 18 months
Maximum tolerated dose as measured by frequency of dose limiting toxicities
Measured: Four (4) weeks after first dose
Secondary outcomes (3)
Peak plasma concentration (Cmax) of VX15/2503
Measured: Four (4) hours after start of infusion
Area under the plasma concentration versus time curve (AUC) of VX15/2503
Measured: Up to seven (7) days after first dose
Half-life of VX15/2503
Measured: Up to 14 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaccinex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Amita Patnaik, MD, Principal investigator, South Texas Accelerated Research Therapeutics, LLCRamesh K Ramanathan, MD, Principal investigator, TGen Clinical Research Service at Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313065
- Sponsor's protocol ID
- VX15/2503-01 v.9
- Status last verified
- Aug 2014
- First submitted
- 4 Mar 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Worzfeld T, Offermanns S. Semaphorins and plexins as therapeutic targets. Nat Rev Drug Discov. 2014 Aug;13(8):603-21. doi: 10.1038/nrd4337.
PubMed 25082288
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of VX15/2503 in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01313065
- Acronym / sponsor ID
- VX15/2503-01 v.9
- Conditions
- Solid Tumors
- Keywords
- VX15/2503, Semaphorin 4D, SEMA4D, CD100, safety, tolerability, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vaccinex Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Mar 2011 (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.
The purpose of this study is to evaluate the safety and tolerability of IV administration of VX15/2503 in patients with advanced solid tumors. The escalation part of the study will determine the maximum tolerated dose (MTD).
Detailed description
VX15/2503-01 is a dose-escalation, open label study to evaluate the safety and tolerability of IV administered VX15/2503 in patients with advanced solid tumors. This will be accomplished by using a dose escalation procedure starting at low doses of VX15/2503 and will continue based on predefined parameters until the maximum tolerated dose is identified.
The study drug, VX15/2503, is a monoclonal antibody that binds to the semaphorin 4D (SEMA4D; CD100) antigen. Semaphorins have been shown to play an important role in certain physiological processes such as vascular growth, tumor progression and immune cell regulation. Experimental evidence suggests that SEMA4D has two mechanisms of action that result in angiogenesis and tumor proliferation and invasion. Antibody neutralization of SEMA4D thus may represent a new therapeutic strategy for cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VX15/2503 | Experimental | Drug: VX15/2503VX15/2503 monoclonal antibody at a concentration of 0.3 mg/kg - 20 mg/kg to be administered intravenously on a weekly dosing cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| VX15/2503Dose escalation will begin at low doses and will gradually increase in each future cohort. The current trial design provides for 7 study cohorts with a 20 mg/kg expansion phase. | Drug | VX15/2503 |
Primary outcome
Safety/tolerability as measured by number of patients with adverse events
Time frame: Up to 18 months
Subject incidence of treatment-emergent adverse events
Maximum tolerated dose as measured by frequency of dose limiting toxicities
Time frame: Four (4) weeks after first dose
3 secondary outcomes
Peak plasma concentration (Cmax) of VX15/2503
Time frame: Four (4) hours after start of infusion
Area under the plasma concentration versus time curve (AUC) of VX15/2503
Time frame: Up to seven (7) days after first dose
Half-life of VX15/2503
Time frame: Up to 14 days after first dose
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 13 Aug 2014.
- Derived from this study: PubMed 25082288Worzfeld T, Offermanns S. Semaphorins and plexins as therapeutic targets. Nat Rev Drug Discov. 2014 Aug;13(8):603-21. doi: 10.1038/nrd4337.
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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.
Amita Patnaik, MD principal investigator
South Texas Accelerated Research Therapeutics, LLC
Ramesh K Ramanathan, MD principal investigator
TGen Clinical Research Service at Scottsdale Healthcare
2 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 VX15/2503 in people with Solid Tumors, run by Vaccinex Inc. at 2 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?
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 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Safety/tolerability as measured by number of patients with adverse events (time frame: Up to 18 months). 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?
On the ClinicalTrials.gov record for NCT01313065, which also lists 1 linked publication.
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 13 Aug 2014.