A Phase 0, Exploratory Study of the Pharmacodynamics of a Single Intratumoral Dose of IMCgp100, a Monoclonal Receptor Anti-CD3 scFv Fusion Protein, in Subjects With Advanced Unresectable Melanoma
This study will test the safety effect of a single dose of the investigational drug IMCgp100
when administered directly into the metastatic melanoma lesion in patients with advanced
metastatic melanoma. IMCgp100 is a drug made up of two components. The first is the T cell
receptor designed to bind specifically and tightly with protein found at high levels on the
surface of melanoma cancer cells and second is an anti-CD3 fragment that is meant to bind to
and activate the T cells. There will be two stage dose regimens each enrolling 3 patients.
Stage 1 dose will 0.00017 mg IMCgp100 and Stage 2 dose will be 0.0017 mg IMCgp100. Inclusion
Criteria: 1. Histologically confirmed dx of advanced unresectable melanoma not requiring
immediate treatment and/or in a window between treatments 2. Two or more cutaneous or
subcutaneous melanoma metastatic lesions 7 to 15 mm in at least one dimension and amenable
to subsequent biopsy 3. Greater or equal to 18 years of age 4. ECOG PS 0-2 5.
Able to provide informed consent and willing to comply with protocol requirements 6. Female
patients must not be of childbearing potential or must have negative serum pregnancy test 48
hours prior to receiving investigational drug 7. Male patients must agree to use reliable
form of birth control throughout study 8. Must have adequate organ system function Exclusion
Criteria: 1. Received any other chemo, immune, radiation or investigational therapy agents
within 2 weeks prior to study treatment 2. Cutaneous metastasis that have received prior
local therapy 3. Pregnant or breastfeeding 4.
History of autoimmune disease 5. Current treatment with steroid or other immunosuppresive
meds 6. Active uncontrolled infection 7. Known HIV infection 8. Uncontrolled seizures 9.
Known delayed wound healing 10. On full dose anticoagulation therapy.
Primary Purpose: Treatment
Adverse Events as a Measure of Safety and Tolerability
To determin the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma. Tumor Lesions, peripheral blood pre- and post-injection will be used to determine the safety and pharmacodynamic properties of single intratumoral doses of IMCgp100 in the setting of advanced unresectable melanoma
United States: Food and Drug Administration
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|