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MP0250 plus BOR+DEX

Phase 1

Multiple Myeloma in Relapse | Monoclonal antibody | Oncology |Molecular Partners AG|Last Updated: Aug 25, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03136653A Phase 2 Trial of MP0250 Plus Bortezomib + Dexamethasone in Patients With Multiple MyelomaPHASE1 COMPLETED 33May 23, 2017Jan 13, 2021Aug 25, 202124 Austria, Czechia +4
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Study Endpoints
Primary Endpoints
Part 1: Overall Response Rate (ORR)
24 months

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.

Part 2: ORR
24 months

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.

Secondary Endpoints
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events
24 months
Number of Participants who Experienced One or More Treatment-Emergent SAEs
24 months
Number of Participants Who Experienced One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3 Adverse Events
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single arm Study MP0250 plus BOR + DEXEXPERIMENTALSingle arm study of MP0250 plus bortezomib + dexamethasone
Interventions
NameTypeDescription
MP0250 plus BOR+DEXBIOLOGICAL6 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

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 ≥...

Countries:AustriaCzechiaDenmarkGermanyItalyPoland
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