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CC-90002

Phase 1

Hematologic Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Aug 12, 2021

CC-90002 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

CC-90002 clinical trials

CC-90002 · 1 trial · 1 indication

Phase 1 1
NCT02367196A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic CancersHematologic Neoplasms
COMPLETED60 Analytics
PHASE1COMPLETED
A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
Hematologic NeoplasmsUnlock trial analytics

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 to 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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Frequently asked questions about CC-90002

What is CC-90002?

CC-90002 is an investigational small molecule developed by Bristol-Myers Squibb for hematologic neoplasms, a group of blood cancers. It was studied in a Phase 1 dose-finding trial in patients with advanced solid and hematologic cancers. CC-90002 is not approved and remains in clinical development.

What is CC-90002 used for in hematologic neoplasms?

CC-90002 was evaluated for the treatment of hematologic neoplasms, which include blood cancers. It was tested in a Phase 1 trial that enrolled 60 patients with advanced solid and hematologic cancers. The study is completed, and CC-90002 has not been approved for any indication.

Who makes CC-90002?

CC-90002 is made by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb developed and sponsored the clinical program for CC-90002 in hematologic neoplasms.

What phase is CC-90002 in?

CC-90002 is in Phase 1 development. It was studied in a single Phase 1 dose-finding trial in patients with advanced solid and hematologic cancers. That trial is completed, and CC-90002 is investigational and not approved for any use.

What clinical trials is CC-90002 in?

CC-90002 was studied in one clinical trial, NCT02367196, titled A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers. The trial enrolled 60 patients across the United States and Spain and is completed.

Is CC-90002 FDA approved?

CC-90002 is not FDA approved. It is an investigational small molecule that completed a Phase 1 dose-finding trial in patients with advanced solid and hematologic cancers. Bristol-Myers Squibb has not announced approval for CC-90002 in hematologic neoplasms or any other indication.