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Cabiralizumab

Phase 1

Advanced Malignancies | Monoclonal antibody | Other |Bristol-Myers Squibb Company|Last Updated: Dec 21, 2020

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03158272A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has SpreadPHASE1 COMPLETED 19 — — May 25, 2017Oct 23, 2019Dec 21, 20204 Japan
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Study Endpoints
Primary Endpoints
Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy
28 days (from first day of treatment)

The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants Who Died - Carbiralizumab Monotherapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.

Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months

The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.

Secondary Endpoints
Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MonotherapyEXPERIMENTALCabiralizumab administered as a single agent intravenous formulation
Combination TherapyEXPERIMENTALCabiralizumab will be administered in combination with Nivolumab as an intravenous formulation
Interventions
NameTypeDescription
CabiralizumabBIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Performance status 0-1 * Adequate organ function * Cohort M1, 2 and C1: Measurable disease * Cohort M1, M2 and C1: Subjects must have histologic or cytologic...

Countries:Japan
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