Phase I Study of IMCgp100 in Advanced Malignant Melanoma V1.0

• Research type

  Research Study

• Full title

  A Phase 1, Open label, Dose Finding Study to Assess the Safety and Tolerability of IMCgp100, a Monoclonal T Cell Receptor anti-CD3 scFv Fusion Protein in Patients With Advanced Malignant Melanoma.

• IRAS ID

  48202

• Contact name

  Mark Middleton

• Sponsor organisation

  Immunocore Ltd

• Eudract number

  2010-019290-15

• ISRCTN Number

  n/a

• Research summary

  This will be the first clinical trial of IMCgp100 in patients with advanced malignant melanoma. This is a Phase 1, open label, dose??finding study to assess the safety and tolerability of IMCgp100, a Monoclonal T Cell Receptor anti-CD3 scFv Fusion Protein, in patients with advanced malignant melanoma. Eligible patients will have Stage IV disease or unresectable Stage III disease. The study will be conducted in 2 parts; a dose: escalation (Part 1) and a dose: expansion (Part 2). In Part 1, approximately 21-33 patients will be enrolled. In Part 2, a total of 20 patients will be enrolled. If patients receive the two additional cycles they will be on study for up to 6 months. The study will be conducted at 3 NHS trust sites in the UK.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/47

• Date of REC Opinion

  18 Jun 2010

• REC opinion

  Favourable Opinion