Clinical Trials

Date: 2017-07-26

Type of information: Recruitment of the first patient

phase: 1-2

Announcement: recruitment of the first patient

Company: OncoQuest (Canada)

Product: oregovomab in combination with Hiltonol®

Action mechanism:

monoclonal antibody/TLR3 agonist. Oregovomab (MAb B43.13) is a monoclonal antibody targeting for the circulating tumour-associated antigen CA125 (also designated MUC16), which is shed from the surface of human epithelial ovarian cancer cells. The antibodies induce broad cellular and humoral immune responses against CA125 via complex formation. Unlike free CA125, CA125-MAb B43.13 complexes can prime dendritic cells, leading to downstream activation of T-Cells.
Hiltonol is a TLR3 agonist.

Disease: ovarian cancer

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

This is a Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be active in advanced cancer, but which have not previously been used together. This study will assess the approach as to whether these two drugs can safely add to the response seen with either drug alone, both of which have doses that are based on prior studies.
Subjects with stable disease for whom a 12 week break from therapy for their persistent and progressive advanced ovarian cancer is appropriate, who have signed informed consent and for whom baseline clinical information is completed, will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for to look for a CA125 specific T cell response at 12 weeks before initiating any additional therapy according to the best clinical judgment of the investigator. At week 16 the subjects will receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an additional blood draw for analysis of T-cell response. (NCT03162562)

Latest news:

• On July 26, 2017, OncoQuest announced the enrollment of the first patient in a Phase 1/2 clinical study to evaluate the use of oregovomab in combination with Hiltonol®, an experimental TLR3 agonist acting as an immune adjuvant, in ovarian cancer patients in the recurrent setting. This clinical trial is being conducted at Florida Hospital Cancer Institute in Orlando, Florida with Dr. Robert Holloway as Principal Investigator and at Virginia Commonwealth University's Massey Cancer Center in Richmond, Virginia, with Dr. William McGuire as the Principal Investigator. The clinical trial is managed and monitored by Veristat, a full service Clinical Research Organization (CRO) in Southborough, Massachusetts.
This is the second Phase 1/2 study evaluating oregovomab in combination with other drugs in the recurrent ovarian cancer setting. In the first trial, which was launched in May 2017 and has accrued 6 patients, oregovomab is being used in combination with nivolumab, a checkpoint inhibitor (NCT03100006).