Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma
IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The drug is designed to target melanoma cells and stimulate immune cells to kill them. This trial is designed to establish the level of drug that can be given to a patient that is tolerable. It also designed to look for signals that the drug is working as intended.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- Definition of the maximum tolerated dose and evaluation of the safety and tolerability of multiple injections of IMCgp100 [ Time Frame: 28 months ] [ Designated as safety issue: Yes ]
The outcome measure of part 1 of the trial is the definition of the maximum tolerated dose based on dose limiting toxicity and pharmacokinetics in patients with stage IV or stage III unresectable malignant melanoma.
The outcome measure of part 2 of the trial is the evaluation of the safety and tolerability of IMCgp100 following multiple IV administrations of IMCgp100 given at the dose recommended from part 1 of the study.
- Characterisation of the pharmacokinetics and changes in tumour volume following IMCgp100 administration [ Time Frame: 28 months ] [ Designated as safety issue: Yes ]The secondary outcome measures for this trial are the characterisation of the pharmacokinetics of IMCgp100 following single and repeat administration, evaluation of the incidence of anti-drug antibodies and the assessment of tumour volume following IMCgp100 infusion.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Ascending doses from 0.000005 to 0.003645mg/kg to be given by intravenous infusion over 4 hours. Repeat treatment is weekly doses over a 6 week cycle.
Other Name: ImmTACgp100
IMCgp100 is a bispecific biologic incorporating an engineered T cell receptor (TCR) specific for a peptide antigen derived from the protein gp100 presented in the context of HLA A2 on the surface of melanoma cells. The TCR is fused to an anti-CD3 scFv fragment that recruits and activates non-melanoma specific T cells (killer T cells) in physical contact with the cancer T cell. This is a Phase I study designed to assess the safety profile and establish a tolerable dose of IMCgp100 in HLA A2 positive malignant melanoma patients. In the second part of the trial, patients will receive an extended course of treatment with a view to assessing the effect of the drug on disease. Patients in the dose escalation phase may also be offered repeat treatment with a dose that has been demonstrated to be tolerable.
|Contact: Yvonne McGrath, PhDemail@example.com|
|United States, Connecticut|
|Yale Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06520-8028|
|Contact: Matthew Madura 203-737-8367 firstname.lastname@example.org|
|Principal Investigator: Mario Sznol, MD|
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Drug Development Unit referral line 615-339-4214|
|Principal Investigator: Jeffrey R Infante, MD|
|Queen Elizabeth Hospital||Recruiting|
|Birmingham, United Kingdom|
|Contact: Neil Steven, PhD, FRCP|
|Principal Investigator: Neil Steven, PhD, FRCP|
|Cambridge, United Kingdom|
|Contact: Pippa G Corrie, PhD, FRCP|
|Principal Investigator: Pippa G Corrie, PhD, FRCP|
|The Beatson Institute||Recruiting|
|Glasgow, United Kingdom|
|Contact: Jeff Evans, MD, FRCP|
|Principal Investigator: Jeff Evans, MD, FRCP|
|St James Hospital||Recruiting|
|Leeds, United Kingdom|
|Contact: Clive Mulatero, PhD, MRCP|
|Principal Investigator: Clive Mulatero, PhD, MRCP|
|NIHR Biomedical Research Centre||Recruiting|
|Oxford, United Kingdom|
|Contact: Mark R Middleton, PhD, FRCP|
|Principal Investigator: Mark R Middleton, PhD, FRCP|
|Study Director:||Yvonne McGrath, PhD||Immunocore Ltd|