Dose Escalating Study of Foxy-5 in Breast-, Colon- or Prostate Cancer Patients
Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
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).