A phase 1A/II study of HCD122 in advanced lymphoma

• Research type

  Research Study

• Full title

  A phase IA/II multi-centre open label study of HCD 122 administered once weekly for four weeks in adult patients with advanced non Hodgkins or Hodgkins lymphoma who have progressed after at least two prior therapies.

• IRAS ID

  7240

• Sponsor organisation

  Novartis

• Eudract number

  2007-004888-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  HCD122 belongs to a class of drugs called monoclonal antibodies. Monoclonal antibodies are so called because they come from a single cell and work by recognising the protein on the surface of the cancer cell and then locking onto it (like a key in a lock). They destroy the cancer by triggering the body's immune system to attack the cancer cell causing the cell to kill itself. HCD122 is being studied as a single agent in this Phase I clinical trial designed to characterise safety, tolerability, study the biochemical and physiological effects of HCD122 and mechanisms of action (pharmacodynamics)), the action of HCD122 in the body over a period of time, including the processes of absorption, distribution, localisation in tissues, biotransformation and excretion (pharmacokinetics) and anti-tumor activity when the drug is administered intravenously once weekly for 4 weeks in adult subjects with advanced lymphoma whose disease has progressed after at least one prior rituximab therapy. Lymphoma encompasses two large groups of cancers, namely non- Hodgkin??s lymphoma (NHL) and Hodgkin??s lymphoma (HL). HCD122 offers potential clinical use in multiple subtypes of B-cell related lymphomas. The 5 B-cell lymphoma subtypes studied in this trial are follicular lymphoma, marginal zone lymphoma/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma, mantle cell lymphoma, and Hodgkin??s lymphoma.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/5

• Date of REC Opinion

  19 Feb 2009

• REC opinion

  Further Information Favourable Opinion