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MSC-1

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Apr 5, 2024

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03490669Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv Solid TumorsPHASE1 COMPLETED 41May 21, 2018Sep 23, 2019Apr 5, 20247 United States, Canada +1
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Study Endpoints
Primary Endpoints
Evaluate the safety and tolerability of MSC-1 and determine the recommended dose for MSC-1 monotherapy for further evaluation in the expansion part of the study
Patients will be evaluated for approximately 6 months or until disease progression

Assessment of frequency \& severity of adverse events

Assess the preliminary anti-tumor activity of MSC-1 monotherapy
Patients will be evaluated for approximately 6 months or until disease progression

Determine objective response rate (ORR)

Secondary Endpoints
Confirm safest dose of MSC-1 for further study
Patients will be evaluated for approximately 6 months or until disease progression
Characterize the PK of MSC-1
Patients will be evaluated before and after each dose of MSC-1 for approximately 6 months or until disease progression. PK will be evaluated more frequently for the first 2 cycles of treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALMultiple dose levels of MSC-1 treatment once every 3 weeks
Dose ExpansionEXPERIMENTALMSC-1 treatment at the recommended Phase 2 dose once every 3 weeks
Interventions
NameTypeDescription
MSC-1BIOLOGICALhumanized monoclonal antibody for intravenous administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria (All patients): * Confirmed Advanced Unresectable Solid Tumor * Measurable disease by RECIST 1.1 by CT or MRI * Documented disease progression on or following last line of therapy * Archival tumor sample for submission * ECOG performance status 0 or 1 * Resolution of all acute, r...

Countries:United StatesCanadaSpain
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