Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma | Recruiting
Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma

Trial Source

There is no location for this trial

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Health Conditions
  • Malignant Melanoma
Primary Contact Details
Recruitment Status
Primary Trial ID Number
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 establish the best dosing schedule for the drug and to look for signals that the drug is working as intended.
Research Details
  • 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 antibody single-chain variable fragment (scFv) 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. The study has two treatment arms with different treatment schedules, weekly or daily dosing. Each treatment arm in the study has two parts. In the first part, dose escalation, the safety and tolerability of the drug are examined and the optimal dose of drug is established. 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.
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Drug : IMCgp100

Study Arm Groups : IMCgp100 weekly dosing regimen, IMCgp100 daily dosing regimen

Intervention Type
See Interventions above
Primary Outcome Measures
  • Definition of the maximum tolerated dose (MTD) and evaluation of the safety and tolerability of multiple injections of IMCgp100 for each of two treatment regimens (weekly dosing and daily dosing); 28 months
Secondary Outcome Measures
  • Characterisation of the pharmacokinetics and changes in tumour burden following IMCgp100 administration; 28 months
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
18 Years - N/A
Who Can Participate
Number of Participants
Participant Inclusion Criteria
  • Inclusion 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 ≤ 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. ≥ 18 years old.
  • 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • 6. For patients in the Dose-Expansion part only, measurable disease according to RECIST
  • criteria. For patients in the Dose-escalation part of the study, only 'assessable
  • disease' is required.
  • 7. Life expectancy >3 months.
  • 8. Blood tests within the following parameters:
  • 1. Platelet count ≥100 x 109/L
  • 2. Haemoglobin ≥10g/dL
  • 3. Calculated creatinine clearance ≥60 mL/min using the modified Cockcroft-Gault
  • equation
  • 4. Neutrophil counts ≥1x109/L
  • 5. Lymphocyte count ≥0.5x109/L
  • 9. Female patients of childbearing potential must use maximally effective birth control
  • during the period of therapy, must be willing to use contraception for 6 months
  • following the last study drug infusion and must have a negative urine or serum
  • pregnancy test upon entry into this study. Otherwise, female patients must be
  • postmenopausal (no menstrual period for a minimum of 12 months) or surgically
  • sterile.
  • 10. Male patients must be surgically sterile or willing to use a double barrier
  • contraception method upon enrolment, during the course of the study, and for 6 months
  • following the last study drug infusion.
  • 11. Able to give informed consent.
  • Exclusion Criteria:
  • 1. Symptomatic brain metastases that are unstable, require steroids, or that have
  • required radiation within the last 28 days
  • 2. Other active malignancy in the past 5 years except carcinoma in situ, completely
  • excised non-melanomatous skin cancer or any other malignancy that in the opinion of
  • the investigator is considered to be cured.
  • 3. Comorbid medical condition that would increase the risk of toxicity in the opinion of
  • the investigator or sponsor. Any symptomatic ongoing infection must be resolved
  • before the patient can be treated in the study.
  • 4. Uveitis
  • 5. Had myocardial infarction within 1 year before enrolment, symptomatic congestive
  • heart failure (New York Heart Association >Class II), unstable angina or unstable
  • cardiac arrhythmia requiring medication.
  • 6. Has an ejection fraction <50%.
  • 7. Clinically significant electrocardiogram (ECG) changes that obscure the ability to
  • assess the RR, PR and QT intervals. Patients with QTc calculated by Bazetts or
  • locally preferred formula which is greater than 500ms.
  • 8. Has hepatic function as follows:
  • 1. Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
  • 2. Alanine aminotransferase >2.5 x ULN
  • 3. Bilirubin >2.0 x ULN
  • 4. Prothrombin time or partial thromboplastin time>1.5 x ULN
  • 9. Bleeding diathesis.
  • 10. Immunosuppressive condition or treatment including previous transplantation,
  • splenectomy or known HIV infection.
  • 11. Has a history of adult seizures.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Trial Contact(s)
Primary Trial Contact
Namir Hassan, PhD
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom, United States
Scientific 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
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
Immunocore Ltd
Key Dates

Recruitment Start Date

Sep 2010

Recruitment End Date

Jul 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

28 Sep 2010

Last Updated

14 Aug 2015