ANV419 - Phase 1/2 Solid Tumours

• Research type

  Research Study

• Full title

  ANV419 Single Agent (Parts A-C) or Combination (Part D) First in Human Study Phase 1/2: Open-label, Dose Escalation and Expansion Study in Patients with Relapsed/Refractory Advanced Solid Tumors

• IRAS ID

  1003590

• Contact name

  Christophe Bucher

• Sponsor organisation

  Anaveon AG

• Eudract number

  2020-004569-37

• Research summary

  Immuno-oncology therapies, treatments that use body’s immune system to fight cancer, including Interleukin-2 (IL-2), a type of cytokine (important messenger protein in the immune system), and IL-2 derived molecules, play a role in the fight against solid tumors. IL-2 has however been limited by its tolerability issues and the stimulation of regulatory T-cells growth (a type of white blood cell that plays a key role in fighting infection and disease, and regulate the immune system) which limits the anti-cancer effect of CD8 (a cellular protein that characterises T-cells that can kill tumour cells) and rapid cell growth of natural killer IL-2; immune cells that are known to destroy tumor cells.

  ANV419 is an IL-2 receptor agonist (a molecule that binds to a receptor and causes the same action as the substance that normally binds to the receptor) and has the potential to overcome IL-2 limitations by causing anti-tumor effects without regulatory T-cells growth.

  As a new study drug, ANV419, has the potential to deliver a benefit to cancer patients by displaying a safety and efficacy (how well it works) profile based on specific cellular activation and proliferation.

  An early phase, open-label research study (where both the participant and the investigator know what the participant is receiving) will be conducted to evaluate the initial efficacy and safety profile of ANV419 in solid tumours.

  The primary aim of the research study is to assess the safety of ANV419 alone during Phase 1 (Parts A&B) in order to identify a suitable dose for Phase 2 development (Parts C&D).

  Part A will identify the best dose of ANV419. Part B will confirm the safety and the best dose of ANV419. Part C will identify how well ANV419 works on its own. The study may be expanded further in part D to identify the safest and best dose of ANV419 when used together with established cancer treatment and how well it works. Up to 50-80 adult participants are expected to be treated in total.

  Lay Summary of Results

  According to the HRA there is no requirement to provide a lay summary part of your final report. The sponsor, Anaveon, have provided justification that as this is a first in human study and other studies are still ongoing that it does not wish to provide a lay summary of results.
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0213

• Date of REC Opinion

  3 Jun 2021

• REC opinion

  Further Information Favourable Opinion