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MKC1106-MT · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Low-Dose Peptide Cohort | EXPERIMENTAL | - |
| High-Dose Peptide Cohort | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| Biological: MKC1106-MT | BIOLOGICAL | Cancer Vaccine, Immunotherapy |
| Biological: MKCC1106-MT | BIOLOGICAL | Cancer Vaccine, Immunotherapy |
| MKC1106-MT | BIOLOGICAL | Cancer Vaccine, Immunotherapy, 500 ug |
Inclusion Criteria: Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer \[AJCC 6th edition\] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists. Patients enrolled in the Phase 2 portion of t...
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MKC1106-MT is an investigational monoclonal antibody therapy being studied for the treatment of advanced melanoma, including Stage III and Stage IV melanoma. It is a multi-component immune based therapy designed to stimulate an immune response against melanoma. It is not approved and remains in clinical development.
MKC1106-MT is being studied for use in advanced melanoma, specifically Stage III and IV melanoma and melanoma of the skin. Research has focused on its safety and its ability to generate an immune response in patients with these conditions. It has not been approved for any indication.
MKC1106-MT is developed by MannKind Corporation, which trades on the Nasdaq under the ticker MNKD. The company is the sponsor behind the clinical program evaluating this monoclonal antibody therapy in melanoma.
MKC1106-MT is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 1 program has been completed, with no trials currently active.
MKC1106-MT has been evaluated in Phase 1 trials including NCT00688090, which studied safety and immune response in patients with advanced melanoma, and NCT00033228, which studied vaccine therapy in Stage IV melanoma. Both trials are completed and enrolled 19 patients each in the United States.
Yes. MKC1106-MT is also referred to as Biological: MKC1106-MT, which is the designation used in clinical trial listings. Both names refer to the same investigational monoclonal antibody therapy developed by MannKind Corporation for advanced melanoma.