A phase I clinical trial, evaluating the therapeutic vaccine hVEGF26-104/RFASE in patients with advanced cancer
- Conditions
- cancer, advanced solid tumorskanker, gemetastaseerde solide tumor
- Registration Number
- NL-OMON20622
- Lead Sponsor
- VU University Medical Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. Histologically confirmed advanced, solid malignancy;
2. Refractory or not amenable to standard therapy;
Exclusion Criteria
1. Major surgery within 28 days before the initiation of study treatment;
2. Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE;<br /><br>2. To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in serum, defined as a VEGF level below 9,0 pg/mL.
- Secondary Outcome Measures
Name Time Method 1. The anti-VEGF antibody titer, induced by hVEGF26-104/RFASE administration;<br /><br>2. To determine the effective dose of hVEGF26-104/RFASE required to neutralize VEGF in plasma and in a platelet sample;<br /><br>3. The effect of VEGF neutralization in a functional Ba/F3-R2 cell proliferation assay.