CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers.
CC-90002-ST-001 is an open-label, Phase 1, dose escalation, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers. The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002. Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab in subjects with CD20-positive NHL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California San Francisco
San Francisco, California, United States
Dose-Limiting Toxicity (DLT)
Number of participants with a DLT
Time frame: Up to 18 months
Non-Tolerated Dose (NTD) - Part A
Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
Time frame: Up to 18 months
Maximum Tolerated Dose (MTD) - Part A
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.
Time frame: Up to 18 months
Non-Tolerated Dose (NTD) - Part B
Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
Time frame: Up to 24 months
Maximum Tolerated Dose (MTD) - Part B
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.
Time frame: Up to 24 months
Antitumor efficacy
Determined by response rates of each tumor type using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and other tumor-appropriate response criteria.
Time frame: Up to 36 months
Pharmacokinetics - Cmax
Maximum observed concentration in serum
Time frame: Cycle 1 and beyond; and after discontinuation
Pharmacokinetics - AUC
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Yale University School of Medicine
New Haven, Connecticut, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona), Spain
Hospital Val d'Hebron
Barcelona, Spain
Duran i Reynals Institut Catala d'Oncologia
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
...and 3 more locations
Area under the serum concentration - time curve
Time frame: Cycle 1 and beyond; and after discontinuation
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Time frame: Cycle 1 and beyond; and after discontinuation
Pharmacokinetics - T1/2
Terminal half-life (T1/2)
Time frame: Cycle 1 and beyond; and after discontinuation
Pharmacokinetics - CL
Total body clearance of the drug from serum
Time frame: Cycle 1 and beyond; and after discontinuation
Pharmacokinetics - Vmax
Volume of distribution at steady-state
Time frame: Cycle 1 and beyond; and after discontinuation
Anti-Drug Antibodies (ADAs)
Determine the presence and frequency of anti-drug antibodies
Time frame: Cycle 1 and beyond; and after discontinuation
Overall Survival - Part B
Measured as the time from the first dose of CC-90002 to death due to any cause.
Time frame: Up to 2 years
Progression-free survival- Part B
Defined as the time from the first dose of CC-90002 to the first occurrence of disease progression or death from any cause
Time frame: Up to 2 years