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Clinical Trials

Date: 2018-09-12

Type of information: Recruitment of the first patient

phase: 1-2

Announcement: recruitment of the first patient

Company: Innate Pharma (France) MedImmune (USA - global biologics arm of AstraZeneca (UK)

Product: durvalumab (Imfinzi®) and IPH5401

Action mechanism:

  • monoclonal antibody/immune checkpoint inhibitor. Durvalumab 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. This antibody blocks PD-L1 interactions with PD-1 and CD80, countering the tumor’s immune-evading tactics and inducing an immune response.
  • Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors. Complement cascade factor 5a (C5a), secreted by tumor cells, attracts and stimulates C5aR-overexpressing myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory mediators, immunosuppressive cytokines and angiogenic factors. They potently suppress T and NK cells and hamper the activities of PD-1/PD-L1 checkpoint blockers.
  • IPH5401 is a first-in-class fully human antibody that blocks the binding of C5a to C5a receptors (C5aR), thereby reducing the accumulation and activation of myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Treatment with IPH5401 may unleash anti-tumor activities of T cells and NK cells. Preclinical experiments support development of IPH5401 in combination with PD-1/PD-L1 checkpoint blockers or other cancer immunotherapies.

Disease: solid tumors, including non small-cell lung cancer (NSCLC) with secondary resistance to prior immuno-oncology (IO) treatment and IO-naïve hepatocarcinoma (HCC)

Therapeutic area: Cancer - Oncology

Country: France, USA

Trial details:

  • In January 2018, Innate Pharma and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a non-exclusive clinical trial collaboration to evaluate the combination of IPH5401 and durvalumab in a Phase I study for patients with selected solid tumors. The study is conducted by Innate and the costs are equally shared by both parties.
  • The  STELLAR (SelecTivE bLocking of compLement receptor C5AR to boost immune response and improve cancer outcomes)-001  is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.
  • The two-part study design includes an initial dose escalation phase to explore three doses of IPH5401 in combination with durvalumab in selected solid tumors. The first cohort will include a two-week run-in period evaluating the safety of IPH5401 prior to performing the combination dosing. At the highest dose of IPH5401, two dosing schedules will be evaluated. The recommended dosing regimen will then be used in the subsequent expansion part of the study. (NCT03665129)

Latest news:

  • • On September 12, 2018, Innate Pharma announced that the first patient has been enrolled in the Phase I dose escalation and expansion study (STELLAR-001*) evaluating IPH5401 in combination with durvalumab (Imfinzi®) for the treatment of patients with solid tumors, including non small-cell lung cancer (NSCLC) with secondary resistance to prior immuno-oncology (IO) treatment and IO-naïve hepatocarcinoma (HCC).

Is general: Yes