Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MP0250
MP0250 plus BOR+DEX · 2 trials · 2 indications
Defined as the number of participants achieving a complete response (CR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 1.
Defined as the number of participants achieving a confirmed, stringent complete response (sCR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator in part 2.
| Arm | Type | Description |
|---|---|---|
| Single arm Study MP0250 plus BOR + DEX | EXPERIMENTAL | Single arm study of MP0250 plus bortezomib + dexamethasone |
| MP0250 | EXPERIMENTAL | see section "intervention description" below |
| Name | Type | Description |
|---|---|---|
| MP0250 plus BOR+DEX | BIOLOGICAL | 6 mg/kg or 8 mg/kg or 12 mg/kg of MP0250, IV (in the vein,) on day 1 of each 21 day cycle. Bortezomib and Dexamethasone according to label. Number of Cycles: until progression or unacceptable toxicity develops. |
| MP0250 | DRUG | Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions. |
Inclusion Criteria: 1. Patients with MM who have received: * Part 1 ≥2 lines of therapy (including bortezomib and an IMiD) and have shown no response (i.e. stable disease) to, have progressed on the most recent treatment or have progressed within 60 days of the most recent therapy * Part 2 ≥...
MP0250 plus BOR+DEX is an investigational combination treatment that pairs the monoclonal antibody MP0250 with bortezomib (BOR) and dexamethasone (DEX). It was studied in patients with relapsed multiple myeloma and in patients with advanced solid neoplasms. The combination remains in clinical development and is not an approved therapy.
MP0250 plus BOR+DEX was studied for the treatment of multiple myeloma in relapse, where bortezomib and dexamethasone are combined with the monoclonal antibody MP0250. A Phase 1 trial, NCT03136653, enrolled 33 patients with relapsed multiple myeloma across Austria, Czechia, Denmark, Germany, Italy, and Poland. The regimen is investigational.
MP0250 plus BOR+DEX is being developed by Molecular Partners AG, which trades under the ticker MOLN. The company is the sponsor of the clinical program evaluating the monoclonal antibody MP0250 in combination with bortezomib and dexamethasone. Bortezomib and dexamethasone are established agents used as the backbone of the combination.
MP0250 plus BOR+DEX is in Phase 1 clinical development. The relapsed multiple myeloma combination trial, NCT03136653, is listed as a Phase 1 study and has completed. A separate first-in-human Phase 1 study of MP0250 in cancer patients has also completed. The combination is investigational and has not been approved by the FDA.
Two completed Phase 1 trials cover MP0250. NCT03136653 tested MP0250 plus bortezomib and dexamethasone in 33 patients with relapsed multiple myeloma in six European countries. NCT02194426 was a first-in-human study of MP0250 in 58 cancer patients with neoplasms in Spain, Switzerland, and the United Kingdom. No trials are currently active.