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CC-95775

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

CC-95775 is an investigational small molecule being studied for the treatment of relapsed or refractory Non-Hodgkin Lymphoma. It is also being evaluated in advanced solid tumors. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes CC-95775?

CC-95775 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational oncology drug.

What phase is CC-95775 in?

CC-95775 is in Phase 1 clinical development. A Phase 1 study has been completed to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors and relapsed or refractory Non-Hodgkin Lymphoma.

What clinical trials is CC-95775 in?

CC-95775 has one completed clinical trial, NCT04089527, which was a Phase 1 study in patients with advanced solid tumors and relapsed or refractory Non-Hodgkin Lymphoma. The trial enrolled 24 participants and was conducted in France and Spain.

Is CC-95775 FDA approved?

CC-95775 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety and tolerability, and further studies would be needed to establish efficacy and seek regulatory approval.