Date: 2015-08-27
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: AstraZeneca (UK)
Product: durvalumab (MEDI4736) and tremelimumab or AZD9150
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor/antisense oligonucleotide/CXCR2 antagonist. Durvalumab (MEDI4736) is a human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. This antibody is directed against B7-H1, have been shown to block the interaction between B7-H1 and its receptors, PD-1 and CD80 (B7-1). This blockade may help to overcome the immunosuppressive effects of B7-H1 on anti-tumor T cells. Tremelimumab is a fully human monoclonal antibody which binds to the protein CTLA-4, expressed on the surface of activated T lymphocytes. ISIS-STAT3 Rx (AZD9150) is an antisense drug discovered by Isis and being developed to treat patients with cancers with a strong link to STAT3, such as hepatocellular carcinoma. ISIS-STAT3 Rx, also referred to as AZD9150, is designed to specifically reduce the production of signal transducer and activator of transcription 3 (STAT3). STAT3 is a gene that blocks natural cell death and is critical for tumor cell growth and survival. Inhibition of STAT3 has been shown to block the induction of tumor-associated cytokines involved in the progression of cancer, such as IL-6, IL-1, TGFb, and IL-10, which could serve as important biomarkers in clinical studies.
Disease: diffuse large B-cell lymphoma (DLBCL)
Therapeutic area: Cancer - Oncology
Country: France, Ireland, Italy, UK, USA
Trial
details: The purpose of this phase 1b study is to evaluate the safety, tolerability, and efficacy of durvalumab alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory dIffuse large B-cell lymphoma. (NCT02549651)
Latest
news: * On August 27, 2015, a Phase I trial sponsored by AstraZeneca was published on the NIH website ClinicalTrials.gov for durvalumab alone and in combination with either tremelimumab or AZD9150 and is currently recruiting participants.
