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CC-95775

Phase 1

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Bristol-Myers Squibb Company|Trials Updated: Feb 1, 2022

CC-95775 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2019

CC-95775 target and mechanism

Molecular targetBCMA
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

CC-95775 clinical trials

CC-95775 · 1 trial · 1 indication

Phase 1 1
NCT04089527Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin LymphomaLymphoma, Non-Hodgkin
COMPLETED24 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of CC-95775 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma
Lymphoma, Non-HodgkinUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicity (DLT)
C1 Up to approximately 28 days

is defined as any toxicities occurring within the DLT assessment unless the event can clearly be determined to be unrelated to CC-95775.

Maximum Tolerated Dose (MTD)
Part A of the study- estimated 12 months

dose level that could be given such that the estimated DLT probability is closest to 25%.

Non-tolerated Dose (NTD)
Part A of the study-estimated 12 months

The dose that is higher than MTD

Adverse Events (AEs)
From signature of the informed consent until at least 28 days after the last dose of study treatment

Number of participants with adverse event. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study

Secondary Endpoints

Pharmacokinetics - Cmax of CC-95775
Part A and part B of the study, estimated 24 months total
Pharmacokinetics - AUC of CC-95775
Part A and part B of the study, estimated 24 months total
Pharmacokinetics - Tmax of CC-95775
Part A and part B of the study, estimated 24 months total
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CC-95775EXPERIMENTALEscalating dose finding part A of study and extension Part B of the study. In Part A, subjects will be treated with oral capsules of CC-95775 with a schedule of 4d on/ 24d off (Q4W) and a starting dose of 100 mg/day on a 28-day cycle. Dose increments between cohorts will not exceed 100% of the dose in previous cohort. Patients in Part B will be treated with a schedule of 4d on/24d off (Q4W) at the Maximum tolerated dose (MTD) established from Part A.

Interventions

NameTypeDescription
CC-95775DRUGCC-95775
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Subjects must satisfy the criteria below to be enrolled in dose escalation (Part A) and in dose expansion (Part B) of this study. 1. Men and women ≥ 18 years of age, at the time of signing the ICF. 2. Subject must understand and voluntarily sign an ICF prior to any study-specif...

Countries:FranceSpain
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Frequently asked questions about CC-95775

What is CC-95775?

CC-95775 is an investigational small molecule developed by Bristol-Myers Squibb Company (ticker: BMY) for the treatment of non-Hodgkin lymphoma. It is designed to target BCMA. The compound has been studied in a Phase 1 clinical trial in adults with advanced solid tumors and relapsed or refractory non-Hodgkin lymphoma.

What is CC-95775 used for in non-Hodgkin lymphoma?

CC-95775 is being studied for relapsed or refractory non-Hodgkin lymphoma. It is an investigational agent and is not approved for any indication. The Phase 1 trial that evaluated CC-95775 enrolled adults with advanced solid tumors and relapsed or refractory non-Hodgkin lymphoma.

What does CC-95775 target?

CC-95775 targets BCMA, also known as B-cell maturation antigen. BCMA is a molecular target of interest in B-cell malignancies, including non-Hodgkin lymphoma. CC-95775 is a small molecule directed at this target and was evaluated in a Phase 1 study in advanced solid tumors and relapsed or refractory non-Hodgkin lymphoma.

Who makes CC-95775?

CC-95775 is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb sponsored the Phase 1 clinical trial of CC-95775 in patients with advanced solid tumors and relapsed or refractory non-Hodgkin lymphoma.

What phase is CC-95775 in?

CC-95775 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA for any indication. The single Phase 1 trial of CC-95775 has been completed, and no trials of CC-95775 are currently active.

What clinical trials is CC-95775 in?

CC-95775 has been evaluated in one Phase 1 clinical trial, NCT04089527, titled a study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CC-95775 in subjects with advanced solid tumors and relapsed or refractory non-Hodgkin lymphoma. The trial enrolled 24 participants across France and Spain and is completed.