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MP0250

Phase 1

Neoplasms | Small molecule | Oncology |Molecular Partners AG|Last Updated: Aug 7, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02194426First-in-human Study to Investigate the Safety, Tolerability and Blood Levels of the Test Drug MP0250 in Cancer PatientsPHASE1 COMPLETED 58 — — Jul 1, 2014Feb 20, 2018Aug 7, 20194 Spain, Switzerland +1
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Study Endpoints
Primary Endpoints
Proportion of patients with dose limiting toxicities
From the Day 0 (first infusion) up to 35 days
Vital signs
From inclusion (week -4) up to week 56
Frequency of adverse events
From inclusion up to week 56
MP0250 plasma concentration-time profile
From Day 0 (first infusion) up to week 56
Nature of dose limiting toxicities
From the Day 0 (first infusion) up to 35 days
Nature of adverse events
From inclusion up to week 56
Severity of adverse events
From inclusion up to week 56
Blood chemistry values
From inclusion (week -4) up to week 56
Haematology values
From inclusion (week -4) up to week 56
Urine values
From inclusion (week -4) up to week 56
Electrocardiogram measurements
From inclusion (week -4) up to week 56
Pharmacokinetics parameters
From Day 0 (first infusion) up to week 56
Secondary Endpoints
Incidence of anti-drug-antibodies
From the Day 0 (first infusion) up to week 56
Titre of anti-drug-antibodies
From the Day 0 (first infusion) up to week 56
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MP0250EXPERIMENTALsee section "intervention description" below
Interventions
NameTypeDescription
MP0250DRUGIntravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female ≥ 18 years 2. Histologically confirmed and documented advanced or metastatic solid tumour refractory to at least 1 prior regimen of standard treatment or for which no curative therapy is available and for whom MP0250 is a reasonable option 3. Progressive or sta...

Countries:SpainSwitzerlandUnited Kingdom
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Competitive Landscape -Myeloproliferative Neoplasms 53 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536, Luspatercept, Fedratinib, BMS-986158, Ruxolitinib
AbbVie, Inc.ABBV4PHASE3Navitoclax, Ruxolitinib, Celecoxib, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib, Pacritinib, Momelotinib
Geron CorporationGERN2PHASE3Imetelstat, Ruxolitinib
Incyte CorporationINCY11PHASE2itacitinib, Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2MMB, Momelotinib, Luspatercept
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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