US-based Ludwig Cancer Research and the Cancer Research Institute (CRI) have commenced a Phase I/II clinical trial to examine ONCOS-102 in combination with Imfinzi (durvalumab) for the treatment of advanced ovarian and colorectal cancers.
The open-label trial has already completed enrolment and the safety evaluation for the first cohort of patients.
It intends to enrol around 78 adult patients whose colorectal or ovarian cancers have become resistant to all available treatment and whose tumours have spread into the peritoneum, the membrane around the abdominal cavity.
During the trial, the investigators are providing ONCOS-102 directly into the peritoneal membrane, while durvalumab will be given systemically.
The trial will be conducted at various academic centres, including Memorial Sloan Kettering Cancer Center (MSK), Roswell Park Cancer Institute, Sylvester Comprehensive Cancer Center at the University of Miami (UM/Sylvester) and University of Virginia Health System (UVA).
New centres are expected to be added in future to include new patient cohorts.
The trial’s objectives are to assess the safety and preliminary efficacy of the durvalumab and Imfinzi combination, as well as optimise dosing, evaluate the feasibility of peritoneal delivery of ONCOS-102 and provide insights for current and future translational research.
CRI Venture Fund and Clinical Accelerator director Vanessa Lucey said: “Patients diagnosed with advanced ovarian and colorectal cancers that have progressed on standard therapies have very few treatment options available to them.
“Under a unique partnership model, this study leverages the capabilities of two prominent non-profit groups, accelerates innovation with top academic centres, and includes two different bio-pharmaceutical companies.
“This is the type of coordination and collaboration we need to accelerate progress for patients.”
MedImmune, the biologics research and development arm of AstraZeneca that developed durvalumab, and Targovax, which developed ONCOS-102, are also involved in the Phase I/II trial.
Durvalumab is a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), while ONCOS-102 is a serotype 5 adenovirus, a relative of the cold virus, developed to selectively infect and kill cancer cells.