Approval Probability
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Also known as Belantamab SC, GSK2857914
Belantamab · 2 trials · 1 indication
VGPR+ is defined as the percentage of participants with a confirmed VGPR or better (i.e., VGPR, complete response, stringent complete response).
| Arm | Type | Description |
|---|---|---|
| Belantamab SC Dose level (DL)1 /IV DL1/SC DL 2 /SC DL1 | EXPERIMENTAL | Participants will receive Belantamab subcutaneous (SC) dose level 1 (DL1) +Recombinant Human Hyaluronidase PH20 (rHuPH20) in Period 1; followed by Belantamab intravenous (IV) DL1 in Period 2; followed by Belantamab SC DL2 + rHuPH20 in Period 3; further followed by Belantamab SC DL1 + rHuPH20 in Period 4. Dose level 1 is the lowest dose level. |
| Belantamab IV DL1 /SC DL1 /SC DL2 /SC DL1 | EXPERIMENTAL | Participants will receive Belantamab IV DL1 in Period 1; followed by Belantamab SC DL1 + rHuPH20 in Period 2; followed by Belantamab SC DL2 + rHuPH20 in Period 3; further followed by Belantamab SC DL1 + rHuPH20 in Period 4 of the study. Dose level 1 is the lowest dose level. |
| Part 1: Dose escalation and expansion of belantamab monotherapy | EXPERIMENTAL | Belantamab will be administered in participants with RRMM until progressive disease (PD) |
| Part 2: Belantamab and belantamab mafodotin (delivered as separate drugs) dose range finding | EXPERIMENTAL | Participants with RRMM will receive belantamab and belantamab mafodotin |
| Part 3: Belantamab +pomalidomide/dexamethasone in 2L+ RRMM | EXPERIMENTAL | Participants with RRMM will receive belantamab in combination with pomalidomide-dexamethasone backbone. |
| Part 1b: Optional belantamab mafodotin | EXPERIMENTAL | Participants enrolled in Part 1 and Part 2 will be dosed until PD after which they will have the option to receive treatment with single agent belantamab mafodotin. |
| Name | Type | Description |
|---|---|---|
| Belantamab SC | DRUG | Belantamab will be administered via SC route. |
| Belantamab IV | DRUG | Belantamab will be administered via IV route. |
| Recombinant Human Hyaluronidase PH20 (rHuPH20) | DRUG | rHuPH20 will be administered via SC route. |
| Standard of care | DRUG | Participants will receive standard of care: Lenalidomide and/or anti-CD38 mAb as maintenance therapy. |
| Belantamab | DRUG | Belantamab will be administered. |
| Belantamab mafodotin | DRUG | Belantamab mafodotin will be administered. |
| Pomalidomide | DRUG | Pomalidomide will be administered. |
| Dexamethasone | DRUG | Dexamethasone will be administered. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants at the time of signing the Informed Consent Form (ICF) must be aged 18 years old or greater or are of the legal age of consent in the jurisdiction in which the stud...
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Belantamab is an investigational monoclonal antibody being studied for the treatment of multiple myeloma, a cancer of plasma cells in the bone marrow. It is being evaluated both as a monotherapy and in combination with other treatments, as well as in a subcutaneous formulation compared with intravenous administration.
Belantamab is being developed by GSK plc, which trades under the ticker GSK. GSK is running the clinical development program for the drug in multiple myeloma, including studies of both intravenous and subcutaneous formulations.
Belantamab is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Two Phase 1 trials are listed, both currently active, with a combined planned enrollment of 145 participants across multiple countries.
Belantamab is being studied in two Phase 1 trials. NCT07742527 compares a subcutaneous belantamab formulation with intravenous belantamab in multiple myeloma patients receiving standard of care and is not yet recruiting. NCT05714839 is recruiting and evaluates belantamab as monotherapy and in combination treatments.
Belantamab SC refers to the subcutaneous formulation of belantamab, so the two names point to the same drug candidate. The subcutaneous version is being tested in the Phase 1 trial NCT07742527, which compares it against intravenous belantamab in participants with multiple myeloma.
Belantamab is a monoclonal antibody, an antibody-based therapeutic. It is being developed for multiple myeloma and studied as both monotherapy and in combination regimens, with a subcutaneous formulation also under evaluation in a Phase 1 comparison against intravenous dosing.