Date: 2016-10-26
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Abbvie (USA - IL)
Product: venetoclax (RG7601, GDC-0199/ABT-199) and ABBV-838
Action
mechanism: protein inhibitor/B-cell lymphoma 2 (BCL-2) inhibitor/antibody drug conjuste (ADC). Venetoclax (RG7601, GDC-0199/ABT-199 is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signaling system that tells cancer cells to self-destruct. The BCL-2 protein is linked to the development of resistance in certain blood cancers and is expressed in chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). In collaboration with AbbVie, venetoclax is being evaluated in a robust development program as a single agent or in combination with other medicines. There are ongoing Phase II and III studies for venetoclax in CLL, and Phase I and II studies are also ongoing in several other blood cancers, including indolent NHL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and multiple myeloma (MM). Venetoclax was recently granted Breakthrough Therapy Designation by the FDA for the treatment of previously treated CLL with the 17p deletion. ABBV-838 is an antibody drug conjugate (ADC) targeting CS1 (SLAMF7/CD319), a cell-surface glycoprotein that is expressed with high levels and prevalence on multiple myeloma (MM) cells, with normal expression limited to leukocyte subsets (including plasma cells, NK cells, and activated monocytes). This ADC uses monomethyl auristatin E (MMAE) with a cathepsin-cleavable linker, and it binds to a unique epitope on CS1.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This is an open-label, multicenter clinical trial designed to evaluate the safety and potential efficacy of venetoclax and ABBV-838 combination therapy with dexamethasone in participants with relapsed or refractory multiple myeloma (MM) who have received 2 or more prior lines of therapy for multiple myeloma (MM). The study will consist of 2 arms: Arm A and Arm B (if applicable). Each arm will have a dose escalation and dose expansion portion. (NCT02951117)
Latest
news: * On October 26, 2016, a new Phase 1 trial with venetoclax was published on ClinicalTrials.gov (A Study of venetoclax and ABBV-838 Combination Therapy With Dexamethasone in Participants With Multiple Myeloma Whose Cancer Has Come Back or Had No Response to Recent Cancer Treatment).
