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DS-8273a · 1 trial · 1 indication
Safety will be evaluated for all treated subjects using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
| Arm | Type | Description |
|---|---|---|
| DS-8273a & Nivolumab | EXPERIMENTAL | Patient groups (cohorts) will receive a single dose level of DS 8273a \& Nivolumab; DS 8273a will be increased in subsequent cohorts. |
| Name | Type | Description |
|---|---|---|
| DS-8273a | BIOLOGICAL | * Starting Dose: 4 mg/ kg IVQ 3 weeks (Cohort 1) * Dose Escalation: 8 mg/kg IV Q 3 weeks (Cohort 2), 16 mg/kg IV Q 3 weeks (Cohort 3), 24 mg/kg IV Q 3 weeks (Cohort 4), 2 mg/kg IV Q 3 weeks (Cohort -1), 4 mg/kg IV Q 3 weeks (Cohort -2) |
| Nivolumab | BIOLOGICAL | 5 mg/kg IV Q 3 weeks |
Inclusion Criteria: * 1\) Signed Written Informed Consent The signed informed consent form prior to the performance of any study related procedures that are not considered part of standard of care. 2\) Target Population 1. Subjects who are ipilimumab naïve with progressive unresectable Stage I...
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DS-8273a is an investigational monoclonal antibody being studied for the treatment of unresectable Stage III or Stage IV melanoma. It is administered in combination with nivolumab. The drug is currently in Phase 1 clinical development and is not approved by the FDA.
DS-8273a is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with melanoma.
DS-8273a is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial for the treatment of unresectable Stage III or Stage IV melanoma.
DS-8273a has been studied in one clinical trial with the identifier NCT02983006. This Phase 1 trial, titled 'Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma,' was conducted in the United States and has been completed. The trial enrolled 12 participants.
DS-8273a is a monoclonal antibody, a type of targeted therapy that binds to specific proteins in the body. In the context of melanoma, it is being studied in combination with nivolumab to potentially enhance the immune system's ability to fight cancer cells. The exact molecular target of DS-8273a has not been disclosed.