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CC-115

Phase 2

Glioblastoma Multiforme | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 5, 2021

CC-115 development status

Highest phase Phase 2 run by David Reardon, MD (NCT02977780)
Phase scored for BMYPhase 1
Registered trials 2 across 2 sponsors since May 2011

CC-115 target and mechanism

Molecular targetPRKDC, MTOR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

CC-115 clinical trials

CC-115 · 1 trial · 6 indications

Phase 1 1
NCT01353625Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.Glioblastoma Multiforme
COMPLETED118 Analytics
PHASE1COMPLETED
Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.
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Study Endpoints

Primary Endpoints

Dose-Limiting Toxicity
Continuously for 28 days after starting treatment
Non-Tolerated Dose
Continuously for 28 days after starting treatment
Maximum Tolerated Dose
Continuously for 28 days after starting treatment
Maximum Observed Concentration in Plasma of CC-115
Days 1, 2, 15, 16 of treatment
Area Under the Concentration-Time Curve for CC-115
Days 1, 2, 15 and 16 of treatment
Time to Maximum Concentration of CC-115
Days 1, 2, 15, and 16 of treatment
Terminal Half-Life for CC-115
Days 1, 2, 15, and 16 of treatment
Apparent Total Body Clearance of CC-115
Days 1, 2, 15 and 16 of treatment
Apparent Volume of Distribution of CC-115
Days 1, 2, 15, and 16 of treatment
Accumulation Index of CC-115
Days 1, 2, 15 and 16 of treatment

Secondary Endpoints

Pharmacodynamics
Screening (within 28 days prior to first dose of study drug) and Days 1, 2, 8, 15, 22, 28, 155, and end of treatment
Anti-Tumor Efficacy
Every 2-3 months until proof of tumor progression
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CC-115EXPERIMENTAL -

Interventions

NameTypeDescription
CC-115DRUGPart A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: Optimal dose schedule is administered in 28-day cycles until disease progression.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma * Progressed or not tolerated standard therapy, and no further standard therapy is available * Arch...

Countries:United StatesFranceGermanySpain
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Frequently asked questions about CC-115

What is CC-115?

CC-115 is an investigational small molecule developed by Bristol-Myers Squibb Company (NYSE: BMY). It is being studied in oncology, including glioblastoma multiforme, and is in Phase 1 clinical development. CC-115 has not been approved by the FDA and remains an investigational agent.

What is CC-115 used for in glioblastoma multiforme?

CC-115 is being studied for the treatment of glioblastoma multiforme, a type of brain cancer, along with other advanced solid tumors and hematologic malignancies. It is an investigational therapy in Phase 1 development and is not approved for any indication.

What does CC-115 target?

CC-115 targets PRKDC and MTOR. It is an inhibitor of both targets, meaning it is designed to block the activity of these proteins. This dual-target profile is the basis for its study in advanced solid tumors and hematologic malignancies.

Who makes CC-115?

CC-115 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical program evaluating CC-115 in oncology.

What phase is CC-115 in?

CC-115 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program has completed, with one trial conducted and no active trials currently listed.

What clinical trials is CC-115 in?

CC-115 has been evaluated in one completed Phase 1 trial, NCT01353625, titled a study to assess safety and tolerability of oral CC-115 for patients with advanced solid tumors and hematologic malignancies. The trial enrolled 118 patients across the United States, France, Germany, and Spain.