US-based biopharmaceutical firm Verastem has begun dosing patients in a Phase I/II study of avelumab and defactinib combination to treat patients with advanced ovarian cancer.
Avelumab is an investigational, fully human, anti-PD-L1 IgG1 monoclonal antibody that inhibits PD-L1 interactions and is thought to activate T-cells, as well as the adaptive immune system.
Defactinib is an investigational Focal Adhesion Kinase (FAK) inhibitor designed to modulate the tumour microenvironment, improve anti-tumour immunity, and decrease cancer stem cells.
The multicentre, open-label, dose-escalation and dose expansion Phase I/II trial will evaluate the safety, pharmacokinetics, pharmacodynamics and initial observations of clinical activity of the avelumab and defactinib combination.
Verastem chief executive officer and president Robert Forrester said: “Initiation of this clinical trial evaluating the combination of avelumab and defactinib represents an important milestone for Verastem, and together with our collaborators at Merck and Pfizer, we are eager to evaluate the potential of this combination to provide ovarian cancer patients with a new treatment option.”
Conducted in collaboration with Merck and Pfizer, the trial will assess the combination in patients with recurrent or refractory stage III-IV ovarian cancer and is expected to enrol up to 100 patients at approximately 15 sites across the US.
The study will also establish primary objectives such as identification of the recommended Phase II dose (RP2D) and evaluation of the best overall response.
The Phase I/II study will be carried out as two sequential parts Part A (Dose Escalation) and Part B (Expansion), whereby Part A will evaluate about 18 patients and Part B will assess around 80 participants.
Image: Micrograph of a mucinous ovarian tumour. Photo: courtesy of Nephron/Wikipedia.