Clinical trial · Interventional
Phase I Study on VEGF Vaccination in Metastatic Solid Tumors
A Phase I Open-label Clinical Trial, Evaluating the Therapeutic Vaccine hVEGF26-104/RFASE in Patients With Advanced Solid Tumors
NCT02237638CI-TRIAL-00051309completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives of this study are to investigate the safety and tolerability profile of the therapeutic vaccine hVEGF26-104/RFASE and 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hVEGF26-104/RFASE | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hVEGF26-104/RFASE vaccination
- description
- hVEGF26-104/RFASE is investigated in dose escalation in which hVEGF26-104 is escalated from 62.5 ug to 500 ug and RFASE is given in a fixed dose of 20 mg. Three patients are treated at each dose level. If 0 of the 3 patients are observed to have DLT, the dose level is escalated one step for the next cohort. If 1 of the 3 patients shows DLT, 3 additional patients are treated at that dose level. If none of these show DLT, the dose level is escalated for the next cohort; otherwise, the prior dose level is defined as the MTD. At the highest dose level 6 patients will be treated. The recommended dose for a phase II trial will be the lowest dose that results in the most effective VEGF neutralization, together with acceptable safety and toxicity.
- interventionNames
- Biological: hVEGF26-104/RFASE
Primary outcomes (3)
- measure
- Number of participants with serious and non-serious adverse events
- timeFrame
- 10-12 weeks
- measure
- Neutralization of endogenous VEGF in serum
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced, solid malignancy. * Refractory or not amenable to standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Please refer to Appendix II for more information. * Willing and able to give written informed consent * Patient is ≥ 18 years of age at the time of signature of the informed consent * Adequate hematological function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, Hemoglobin ≥ 6.0 mmol/L. * Adequate hepatic function: serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), ALT and AST ≤ 2.5 x ULN (or ≤ 5 times ULN if liver metastases are present). * Adequate renal function: eGFR ≥ 50ml/min * PT-INR/PTT \< 1.5 x ULN, unless coumarin derivatives are used * Activated partial thromboplastin time (APTT) \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed, if this treatment can be interrupted for a biopsy as judged by the treating physician) * Female patients of childbearing potential may be enrolled in the study, if the patient * Has practiced adequate contraception for 30 days prior to first hVEGF26-104/RFASE administration. * Negative pregnancy test * Has agreed to continue adequate contraception for as long as VEGF is neutralized. Exclusion Criteria: * Major surgery within 28 days before the initiation of study treatment * Any serious non-healing wounds, ulcers, or bone fractures within 28 days prior to the initiation of study treatment. * Deep venous thrombosis (DVT) or pulmonary embolus (PE) within 1 year prior to the initiation of study treatment. * Uncontrolled hypertension (systolic \> 150 mmHg and/or diastolic \> 100 mmHg) * The patient is scheduled to receive another vaccination during the DLT period. * A previous serious allergic reaction to a vaccine such as angioedema and anaphylaxis. * Treatment with bevacizumab within 6 weeks prior to the initiation of study treatment. * Uncontrolled auto-immune diseases * Primary or secondary immunodeficiency, including HIV * Treatment with a glucocorticoid derivative in an equivalent dose of ≥ 10mg prednisone a day. * Female patients: the patient is pregnant or lactating. * When the patient is scheduled to receive any other anticancer treatments. * Chemotherapy within 28 days prior to the initiation of study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.