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MKC1106-MT · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | The first cohort of 6 patients received 500 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (\<33%) patients of a 6 patient cohort. |
| Cohort 2 | EXPERIMENTAL | The second cohort of 6 patients received 1000 ug of Synchrovax SEM plasmid DNA vaccine. All patients were to be monitored for dose limiting toxicities DLTs) for a minimum of 2 weeks after their second infusion of vaccine on Day 15 before allowing patients to enroll at the next dose group. The decision to progress to the next dose group was to be based on occurrence of DLTs observed in 1 or fewer (\<33%) patients of a 6 patient cohort. |
| Cohort 3 | EXPERIMENTAL | The third cohort of 6 patients received 1500 ug of Synchrovax SEM plasmid DNA vaccine. The maximum tolerated dose (MTD) was to be determined by the observation of DLT at each dose group. |
| Name | Type | Description |
|---|---|---|
| MKC1106-MT | BIOLOGICAL | Cancer Vaccine, Immunotherapy, 500 ug |
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Must have tumor tissue available for determining antigen expression * At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry * HLA-A2 positive * No brain metastases unless completely resec...
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MKC1106-MT is an investigational monoclonal antibody being studied for the treatment of melanoma, a type of skin cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
MKC1106-MT is being developed by MannKind Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical research to evaluate this investigational therapy for melanoma.
MKC1106-MT is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of melanoma, and its safety and efficacy are still being evaluated in early-stage clinical trials.
MKC1106-MT has been studied in one clinical trial, identified as NCT00033228, titled "Vaccine Therapy in Treating Patients With Stage IV Melanoma." This Phase 1 trial was completed in the United States and enrolled 19 participants aged 18 years and older.
MKC1106-MT is an investigational monoclonal antibody being studied for melanoma. The clinical trial NCT00033228, which evaluated this drug, was titled "Vaccine Therapy in Treating Patients With Stage IV Melanoma," suggesting the therapy may have vaccine-like properties, though it is classified as a monoclonal antibody.