A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
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|ClinicalTrials.gov Identifier: NCT02367196|
Recruitment Status : Recruiting
First Posted : February 20, 2015
Last Update Posted : December 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Neoplasms||Drug: CC-90002 Drug: Rituximab||Phase 1|
CC-90002-ST-001 is an open-label, Phase 1, dose escalation and expansion, 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, followed by expansion in combination with rituximab in subjects with CD20-positive NHL.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Open-Label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Advanced Solid and Hematologic Cancers|
|Actual Study Start Date :||March 12, 2015|
|Estimated Primary Completion Date :||May 28, 2021|
|Estimated Study Completion Date :||May 28, 2021|
Experimental: CC-90002 +/- Rituximab
CC-90002 by intravenous (IV) infusion on a 28 day cycle (PartA); CC-90002 in combination with Rituximab by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL (Part B)
- Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to 18 months ]Number of participants with a DLT
- Non-Tolerated Dose (NTD) - Part A [ Time Frame: Up to 18 months ]Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
- Maximum Tolerated Dose (MTD) - Part A [ Time Frame: Up to 18 months ]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.
- Non-Tolerated Dose (NTD) - Part B [ Time Frame: Up to 24 months ]Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
- Maximum Tolerated Dose (MTD) - Part B [ Time Frame: Up to 24 months ]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.
- Antitumor efficacy [ Time Frame: Up to 36 months ]Determined by response rates of each tumor type using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and other tumor-appropriate response criteria.
- Pharmacokinetics ‐ Cmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Maximum observed concentration in serum
- Pharmacokinetics - AUC [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Area under the serum concentration - time curve
- Pharmacokinetics - tmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Time to peak (maximum) serum concentration
- Pharmacokinetics ‐ T1/2 [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Terminal half‐life (T1/2)
- Pharmacokinetics - CL [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Total body clearance of the drug from serum
- Pharmacokinetics - Vmax [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Volume of distribution at steady-state
- Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 and beyond; and after discontinuation ]Determine the presence and frequency of anti-drug antibodies
- Overall Survival - Part B [ Time Frame: Up to 2 years ]Measured as the time from the first dose of CC-90002 to death due to any cause.
- Progression-free survival- Part B [ Time Frame: Up to 2 years ]Defined as the time from the first dose of CC-90002 to the first occurrence of disease progression or death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02367196
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|United States, Arizona|
|Scottsdale Healthcare Research Institute||Completed|
|Scottsdale, Arizona, United States, 85258|
|University of Arizona Cancer Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|United States, California|
|University of California San Francisco||Completed|
|San Francisco, California, United States, 94143|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06520-8073|
|United States, Texas|
|South Texas Accelerated Research Therapeutics||Completed|
|San Antonio, Texas, United States, 78229|
|Universitaetsklinikum Muenster||Not yet recruiting|
|Muenster, Germany, 48149|
|University Hospital of Ulm||Not yet recruiting|
|Ulm, Germany, 89081|
|ASST Grande Ospedale Metropolitano Niguarda, Milano||Not yet recruiting|
|Milano, Italy, 20162|
|Hospital Universitari Germans Trias i Pujol Can Ruti||Recruiting|
|Badalona (Barcelona), Spain, 08916|
|Hospital Vall d'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|Duran i Reynals Institut Catala d'Oncologia||Not yet recruiting|
|Barcelona, Spain, 08907|
|Hospital Universitario Fundacion Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|Hospital 12 de Octubre||Not yet recruiting|
|Madrid, Spain, 28041|
|Hospital Universitario de Salamanca||Recruiting|
|Salamanca, Spain, 37007|
|Hospital Marques de Valdecilla||Not yet recruiting|
|Santander, Spain, 39008|
|Hospital de la Fe||Not yet recruiting|
|Valencia, Spain, 46009|
|Study Director:||Michael Burgess, MD, PhD||Celgene|