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CC-90002

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

CC-90002 is an investigational small molecule being studied for the treatment of hematologic neoplasms, which are cancers of the blood and bone marrow. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes CC-90002?

CC-90002 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is CC-90002 in?

CC-90002 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Its Phase 1 trial has been completed.

What clinical trials is CC-90002 in?

CC-90002 has one completed Phase 1 clinical trial, NCT02367196, which was a dose-finding study in patients with advanced solid and hematologic cancers. The trial enrolled 60 participants and was conducted in the United States and Spain.

Is CC-90002 FDA approved?

CC-90002 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development and has not been authorized for marketing.