The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL). The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
IV Infusion
Local Institution - 104
Minneapolis, Minnesota, United States
Local Institution - 103
Omaha, Nebraska, United States
Local Institution - 101
Houston, Texas, United States
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Time frame: From enrollment until at least 28 days after completion of study treatment
Dose-limiting toxicity (DLT)
Number of participants with a DLT
Time frame: Up to approximately 18 months
Maximum tolerated dose (MTD)
Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%.
Time frame: Up to approximately 18 months
Overall response rate (ORR)
Is defined as the percent of participants whose best response is CR or PR
Time frame: Up to 2 years after study treatment
Time to response (TTR)
Is defined as the time from the first dose of CC-96673 to tumor response
Time frame: Up to 2 years after study treatment
Duration of response (DOR)
Is defined as the time from tumor response to progression/death
Time frame: Up to 2 years after study treatment
Progression free survival (PFS)
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Local Institution - 102
Seattle, Washington, United States
Local Institution - 201
Toronto, Ontario, Canada
Local Institution - 202
Montreal, Quebec, Canada
Local Institution - UNK-5
Angers, France
Local Institution - 303
Lille, France
Local Institution - 302
Montpellier, France
Hopital Lyon Sud
Pierre-Bénite, France
...and 3 more locations
Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause
Time frame: Up to 2 years after study treatment
Pharmacokinetics - Cmax
Maximum observed serum concentration of drug
Time frame: Up to 24 Months
Pharmacokinetics - AUC
Area under the serum concentration-time curve
Time frame: Up to 24 Months
Pharmacokinetics - tmax
Time of maximum observed serum concentration
Time frame: Up to 24 Months
Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies
Time frame: Up to 24 Months