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RBL001/RBL002 · 1 trial · 1 indication
Number of Patients with adverse events, total number of adverse events, dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| RBL001/RBL002 intranodal administration | EXPERIMENTAL | All participants will be treated with RBL001/RBL002 after allocation to one of the four escalating dose cohorts: * Cohort-1 50 µg RBL001 and 50 µg RBL002 * Cohort-2 100 µg RBL001 and 100 µg RBL002 * Cohort-3 300 µg RBL001 and 300 µg RBL002 * Cohort-4 600 µg RBL001 and 600 µg RBL002 |
| Name | Type | Description |
|---|---|---|
| RBL001/RBL002 | BIOLOGICAL | Each participant will receive 8 repeated intranodal administrations of RBL001 and RBL002 during a time frame of 43 to 51 days. |
Inclusion Criteria: * Stage IIC, IIIA-C or unresectable stage IV of cutaneous melanoma (AJCC 2009 melanoma classification) * First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented...
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RBL001/RBL002 is an investigational monoclonal antibody being studied for the treatment of melanoma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy.
RBL001/RBL002 is being developed by BioNTech SE, a biotechnology company publicly traded under the ticker symbol BNTX. The company is conducting clinical research to evaluate the drug's potential in oncology, specifically for melanoma.
RBL001/RBL002 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is still undergoing evaluation in early-stage clinical research.
RBL001/RBL002 has been studied in one completed Phase 1 clinical trial, identified as NCT01684241. This trial enrolled 29 participants with melanoma and was conducted at sites in Austria and Germany. The study was not randomized, double-blind, or controlled.
RBL001/RBL002 is the name used for the combination of two investigational monoclonal antibodies, RBL001 and RBL002, studied together in a single clinical trial. The trial evaluated the combination in patients with melanoma, and the drug remains in early clinical development.