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CC-90002

Phase 1

Hematologic Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 12, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02367196A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic CancersPHASE1 COMPLETED 60Mar 12, 2015Dec 24, 2020Aug 12, 202113 United States, Spain
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Study Endpoints
Primary Endpoints
Dose-Limiting Toxicity (DLT)
Up to 18 months

Number of participants with a DLT

Non-Tolerated Dose (NTD) - Part A
Up to 18 months

Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.

Maximum Tolerated Dose (MTD) - Part A
Up to 18 months

Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.

Non-Tolerated Dose (NTD) - Part B
Up to 24 months

Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.

Maximum Tolerated Dose (MTD) - Part B
Up to 24 months

Dose that is the last dose level below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT during Cycle 1.

Secondary Endpoints
Antitumor efficacy
Up to 36 months
Pharmacokinetics - Cmax
Cycle 1 and beyond; and after discontinuation
Pharmacokinetics - AUC
Cycle 1 and beyond; and after discontinuation
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Study Design & Arms
AllocationNA
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: CC-90002EXPERIMENTALCC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
Part B: CC-90002 with RituximabEXPERIMENTALCC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
Interventions
NameTypeDescription
CC-90002DRUG -
RituximabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only. 2. At least one site of measurable disease in subjects...

Countries:United StatesSpain
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