Dose Escalating Study of Foxy-5 in Breast-, Colon- or Prostate Cancer Patients
Summary
The Wnt proteins belong to a family of proteins that have been demonstrated to play a role in the formation and dissemination of tumours. The present project focuses on the critical role of the Wnt-5a protein in the pathobiological processes that lead to metastatic cancer disease. WntResearch has identified a formylated 6 amino acid peptide fragment, named Foxy-5, which mimick the effects of Wnt-5a to impair migration of epithelial cancer cells and thereby acting anti-metastatic. The aim of the first clinical phase I study was to establish the recommended dose for a clinical phase II study and enable further development of Foxy-5 as a first in class anti-metastatic cancer drug. The study did not see any DLTs and therefore failed to reach maximum tolerated dose (MTD); no recommended phase II dose (RP2D) could therefore be established based on toxicity. The aim of this study is to continue to establish the safety profile of Foxy-5 in higher doses, and determine the RP2D for later stage development based on any observed DLT's/MTD and further analysis of the pharmacodynamic profile of Foxy-5 to determine the biological response dose (BRD).
Timeline
- Start
- 2016-04
- Primary completion
- 2017-10
- Completion
- 2017-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Foxy-5 | Peptide | 0.8 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 1.3 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 1.8 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 2.3 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 3 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 4 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 5.3 mg/kg | Other |
| Subject | Foxy-5 | Peptide | 7 mg/kg | Other |