IMCgp100 in Advanced Unresectable Melanoma
Drug: IMCgp100 injection
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
To determine 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
- Adverse events [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]Will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.
- Vital signs [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]will be used to determine the safety and tolerability of IMCgp100 at subtherapeutic doses.
- PE examinations findings [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]will be used to determine the safety and tolerability of IMCgp 100 at subtherapeutic doses.
- Peripheral blood samples [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]will be used to examine peripheral cytokine measurements as evidence of product immunoactivity and peripheral T and NK cell numbers, phenotype and activation marker status.
|Study Start Date:||September 2010|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
IMCgp100 will be injected cutaneously or subcutaneously into the metastasis, and peritumoral area if applicable
Drug: IMCgp100 injection
a monoclonal T cell receptor anti-CD3scFv fusion protein
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 immunosuppressive meds 6. Active uncontrolled infection 7. Known HIV infection 8. Uncontrolled seizures 9. Known delayed wound healing 10. On full dose anticoagulation therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209676
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Giorgos Karakousis, MD||Abramson Cancer Center of the University of Pennsylvania|