Date: 2016-06-07
Type of
information: Recruitment of the first patient
phase: 2b
Announcement: recruitment of the first patient
Company: TG Therapeutics (USA - NY)
Product: ublituximab and TGR-1202
Action
mechanism:
- monoclonal antibody/phosphoinositide 3-kinase (PI3K) inhibitor.
- TG-1101 (ublituximab) is a monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen.
- TGR-1202 (formerly known as RP5264) is an orally available PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of phosphoinositide 3-kinase. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-cell lymphocytes. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies.
Disease: diffuse large B-cell lymphoma (DLBCL)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This research study will evaluate the safety and efficacy of TGR-1202 in combination with ublituximab compared to TGR-1202 alone as a possible treatment for Diffuse Large B-cell Lymphoma (DLBCL) that has come back or that has not responded to standard treatment. (NCT02793583)
Latest
news:
- • On June 7, 2016, TG Therapeutics announced the enrollment of its first patient in its registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101 (ublituximab- glycoengineered anti-CD20 monoclonal antibody), in combination with TGR-1202 (PI3K delta inhibitor), as well as TGR-1202 alone, in patients with previously treated Diffuse Large B-Cell Lymphoma (DLBCL). The study, entitled "A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 alone in Patients with Previously Treated Diffuse Large B-Cell Lymphoma," is being led by Owen A. O'Connor, MD, PhD, Professor of Medicine and Experimental Therapeutics, and Director of the Center for Lymphoid Malignancies at Columbia University Medical Center. The primary objective of the study is to assess the efficacy of TGR-1202 alone and in combination with TG-1101 in patients with previously treated DLBCL as measured by Overall Response Rate (ORR). The study will also provide important information as to the contribution of each asset, TGR-1202 and TG-1101, to the combination of both agents. In addition to monitoring for safety and efficacy this study will analyze the impact of cell of origin (GCB vs. ABC ), mutational status and select biomarkers of efficacy.
Is
general: Yes
