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Also known as IMC-20D7S (Cohort 1A)
IMC-20D7S · 1 trial · 1 indication
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
| Arm | Type | Description |
|---|---|---|
| IMC-20D7S (1A-4A Cohorts) | EXPERIMENTAL | Escalating doses up to 30 milligrams per kilogram (mg/kg) administered intravenously (i.v.) every 2 weeks; includes Cohorts 1A, 2A, 3A, and 4A. |
| IMC-20D7S (1B-3B Cohorts) | EXPERIMENTAL | Escalating doses up to 30 mg/kg administered i.v. every 3 weeks; includes Cohorts 1B, 2B, and 3B. |
| Name | Type | Description |
|---|---|---|
| IMC-20D7S (Cohort 1A) | BIOLOGICAL | 5 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A. |
| IMC-20D7S (Cohort 2A) | BIOLOGICAL | 10 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A. |
| IMC-20D7S (Cohort 3A) | BIOLOGICAL | 20 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A. |
| IMC-20D7S (Cohort 4A) | BIOLOGICAL | 30 mg/kg i.v. every 2 weeks. Administered every other week on Days 1 and 15 of each treatment cycle. |
| IMC-20D7S (Cohort 1B) | BIOLOGICAL | 10 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B. |
| IMC-20D7S (Cohort 2B) | BIOLOGICAL | 20 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B. |
| IMC-20D7S (Cohort 3B) | BIOLOGICAL | 30 mg/kg i.v. every 3 weeks. Administered every 3 weeks on Days 1 and 22 of each treatment cycle. |
Inclusion Criteria: * Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy \[for example (e.g.), treatment with cytokines, monoclonal...
IMC-20D7S is an investigational monoclonal antibody developed for the treatment of malignant melanoma, a form of skin cancer. It is also referred to as IMC-20D7S (Cohort 1A). It was studied in an early-stage clinical trial and is not an approved therapy.
IMC-20D7S was studied for use in malignant melanoma, an oncology indication. Its clinical evaluation was limited to a single Phase 1 dose-escalation trial in participants with that condition. It is an investigational agent and is not an approved treatment for melanoma or any other indication.
IMC-20D7S was developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the clinical program evaluating the antibody in malignant melanoma.
IMC-20D7S is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study was an open-label, dose-escalation trial that enrolled 27 participants with malignant melanoma in the United States.
IMC-20D7S was evaluated in one completed Phase 1 trial, NCT01137006, titled an open-label, dose-escalation study in participants with malignant melanoma. The trial enrolled 27 participants aged 18 years and older in the United States and used a controlled design without randomization or double blinding.
Yes. IMC-20D7S (Cohort 1A) is an alternative designation for IMC-20D7S, the monoclonal antibody developed by Eli Lilly and Company for malignant melanoma. Both names refer to the same investigational agent studied in the Phase 1 trial NCT01137006.