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VXM01 · 3 trials · 3 indications
AEs listed together with information on onset, duration, severity, seriousness, relationship to the study drug, relationship to chemotherapy and to the underlying disease, outcome, and action taken. Frequency tables by System Organ Class and preferred term.
Number of dose-limiting toxicities and maximum tolerated dose
| Arm | Type | Description |
|---|---|---|
| VXM01 | EXPERIMENTAL | VXM01 10E6 or 10E7 CFU |
| Placebo | PLACEBO_COMPARATOR | Placebo control |
| Name | Type | Description |
|---|---|---|
| VXM01 | DRUG | Oral immunotherapy targeting VEGFR2 |
| Placebo | BIOLOGICAL | Drink solution |
Inclusion Criteria: 1. Written informed consent, signed and dated 2. Histologically diagnosed intracranial supratentorial malignant glioma (contrast-enhancing anaplastic astrocytoma WHO Grade III or glioblastoma WHO Grade IV). 3. Male or female patients who must be post-menopausal for at least 2 ye...
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VXM01 is an investigational therapy being studied in oncology for colorectal cancer, glioblastoma, and Stage IV pancreatic cancer. It has been evaluated in Phase 1 clinical trials in patients with these tumor types, including operable recurrent glioblastoma, metastatic colorectal cancer with liver metastasis, and locally advanced or inoperable Stage IV pancreatic cancer.
VXM01 targets VEGFR-2, also known as vascular endothelial growth factor receptor 2. By targeting VEGFR-2, the therapy is designed to interfere with tumor angiogenesis, the process by which tumors recruit new blood vessels to support their growth. This mechanism is relevant across the solid tumor types in which VXM01 has been studied.
VXM01 is being developed by OSR Holdings, Inc., which trades under the ticker symbol OSRH. The company is the sponsor of the clinical program evaluating VXM01 in oncology indications including colorectal cancer, glioblastoma, and Stage IV pancreatic cancer.
VXM01 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program has been conducted in Germany and includes studies in glioblastoma, colorectal cancer, and Stage IV pancreatic cancer.
VXM01 has been studied in three completed Phase 1 trials: NCT02718443 in operable recurrent glioblastoma with 14 patients, NCT02718430 in metastatic colorectal cancer with liver metastasis with 6 patients, and NCT01486329 in locally advanced, inoperable and Stage IV pancreatic cancer with 72 patients. All were conducted in Germany.