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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000101-39 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: CC-90002 | Experimental | CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle |
|
| Part B: CC-90002 with Rituximab | Experimental | CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-90002 | Drug |
| ||
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | Number of participants with a DLT | 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. | 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. | 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. | 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
| Pharmacokinetics - Cmax |
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Inclusion Criteria:
Exclusion Criteria:
concurrent second cancers requiring active, ongoing systemic treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Burgess, MD, PhD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34247273 | Derived | Narla RK, Modi H, Bauer D, Abbasian M, Leisten J, Piccotti JR, Kopytek S, Eckelman BP, Deveraux Q, Timmer J, Zhu D, Wong L, Escoubet L, Raymon HK, Hariharan K. Modulation of CD47-SIRPalpha innate immune checkpoint axis with Fc-function detuned anti-CD47 therapeutic antibody. Cancer Immunol Immunother. 2022 Feb;71(2):473-489. doi: 10.1007/s00262-021-03010-6. Epub 2021 Jul 10. |
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| Drug |
|
Maximum observed concentration in serum
| Cycle 1 and beyond; and after discontinuation |
| Pharmacokinetics - AUC | Area under the serum concentration - time curve | Cycle 1 and beyond; and after discontinuation |
| Pharmacokinetics - tmax | Time to peak (maximum) serum concentration | Cycle 1 and beyond; and after discontinuation |
| Pharmacokinetics - T1/2 | Terminal half-life (T1/2) | Cycle 1 and beyond; and after discontinuation |
| Pharmacokinetics - CL | Total body clearance of the drug from serum | Cycle 1 and beyond; and after discontinuation |
| Pharmacokinetics - Vmax | Volume of distribution at steady-state | Cycle 1 and beyond; and after discontinuation |
| Anti-Drug Antibodies (ADAs) | Determine the presence and frequency of anti-drug antibodies | 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. | 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 | Up to 2 years |
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of California San Francisco | San Francisco | California | 94143-1270 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520-8073 | United States |
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
| Hospital Universitari Germans Trias i Pujol Can Ruti | Badalona (Barcelona) | 08916 | Spain |
| Hospital Val d'Hebron | Barcelona | 08035 | Spain |
| Duran i Reynals Institut Catala d'Oncologia | Barcelona | 08907 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital de la Fe | Valencia | 46009 | Spain |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000722662 | CC-90002 |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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