A Phase I Open label, Dose Finding Study of IMCgp100 in Patients with Advanced Malignant Melanoma


Melanoma, skin

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

This is a Phase 1, open-label, dosefinding 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.

Participation Guidelines


Eligibility Criteria

Patients entering this trial will have advanced incurable low volume melanoma and express the Human Leukocyte Antigen (HLA) allele HLA A2 necessary for targeting of the investigational agent.

Inclusion Criteria:

Each patient must comply with the following criteria:

1. Pathologically documented Stage IV malignant melanoma or unresectable Stage III melanoma for which no standard effective therapy exists or for which an appropriate window exists between alternative therapeutic options. Patients for whom early treatment with vemurafenib is indicated e.g. rapidly progressing or symptomatic disease, are excluded from this trial.

2. Previous surgery (other than resection of skin metastases), radiotherapy, chemotherapy, immunotherapy or experimental therapy completed >4 weeks before and all adverse events resolved to &le grade 1. In cases where localised radiotherapy has been applied, treatment with IMCgp100 can be commenced after a two week period.

3. HLA A2 positive.

4. &ge 18 years old.

5. Eastern Cooperative Oncology Group (ECOG) performance status &le1.

6. For patients in the Dose&ndashExpansion part only, measurable disease according to RECIST criteria. For patients in the Dose&ndashescalation part of the study, only &lsquoassessable disease&rsquo is required.

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