NEW YORK – Purple Biotech said on Friday that it has dosed the first patient in a Phase Ib/II clinical trial evaluating CM24 combined with nivolumab (Bristol Myers Squibb's Opdivo) for patients with advanced solid cancers.
The trial — a collaboration between Rehovot, Israel-based Purple and BMS — will assess CM24, a monoclonal antibody targeting CEACAM1, plus the anti-PD-1 immune checkpoint inhibitor nivolumab in three patient cohorts. The first cohort will consist of patients with various types of advanced solid cancers including melanoma, ovarian cancer, colorectal cancer, and papillary thyroid cancer, among others.
Two expansion cohorts will then consist of patients with advanced non-small cell lung cancer (NSCLC) whose cancers have progressed after prior immunotherapy treatment and advanced pancreatic cancer patients, respectively. The pancreatic cancer patients cohort will receive chemotherapy in addition to the CM24-nivolumab combination.
The primary outcome of the study, which will enroll roughly 74 patients, is the safety and preliminary efficacy of the treatment combination. In the NSCLC and pancreatic cancer expansion cohorts, the investigators plan to conduct a biomarker analysis in which they measure CEACAM1 level of expression as well as expression of various immune and adhesion-related molecules.
"Targeting CEACAM1 is a cutting-edge approach utilizing the most current knowledge of the interface of the myeloid and T-cell systems in the neoplastic phenotype," Purple Biotech Chief Medical Officer Bertrand Liang said in a statement. "We look forward to the availability of preliminary data from the first part of this study, which we expect to receive during the second half of this year."