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MP0274

Phase 1

Neoplasms | Small molecule | Oncology |Molecular Partners AG|Last Updated: Jan 10, 2022

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 Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03084926First-in-human Study to Investigate Safety, Blood Levels and Activity of MP0274 in Cancer Patients With HER2-positive Solid TumorsPHASE1 COMPLETED 22Aug 8, 2017Dec 13, 2021Jan 10, 20224 Germany, Switzerland +1
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Study Endpoints
Primary Endpoints
Incidence and severity of adverse events
from first infusion to end-of-study visit, up to 12 months

Number and grading according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

Secondary Endpoints
Pharmacokinetics of MP0274
from first infusion to end-of-study visit, up to 12 months
Preliminary assessment of anti-tumor activity of MP0274
from first infusion to end-of-study visit, up to 12 months
Incidence of anti-drug-antibodies
from first infusion to end-of-study visit, up to 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MP0274EXPERIMENTAL -
Interventions
NameTypeDescription
MP0274DRUGIntravenous infusion of MP0274 as single agent at four planned dose levels, every three weeks until progressive disease, unacceptable toxicity or patient withdrawal for other reasons
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

INCLUSION CRITERIA 1. Have signed and dated written informed consent prior to performing any study procedure, including screening 2. Are ≥ 18 years old on the day of signing informed consent 3. Have histologically confirmed and documented HER2 positive solid tumor malignancy that is unresectable, l...

Countries:GermanySwitzerlandUnited Kingdom
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