A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
- Registration Number
- NCT02367196
- Lead Sponsor
- Celgene
- Brief Summary
CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Men and women, 18 years or older, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only.
- At least one site of measurable disease in subjects with solid tumors and NHL.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
- Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab
- High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
- High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
- Symptomatic central nervous system involvement.
- Impaired cardiac function or clinically significant cardiac disease.
- Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
- Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
- Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
- Major surgery ≤ 2 weeks prior to starting CC-90002.
- Pregnant or nursing females.
- Known HIV infection.
- Known chronic, active hepatitis B or C (HBV/HCV) infection.
- Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
concurrent second cancers requiring active, ongoing systemic treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: CC-90002 CC-90002 CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle Part B: CC-90002 with Rituximab CC-90002 CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL Part B: CC-90002 with Rituximab Rituximab CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
- Primary Outcome Measures
Name Time Method Dose-Limiting Toxicity (DLT) Up to 18 months Number of participants with a DLT
Maximum Tolerated Dose (MTD) - Part A 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 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 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.
Non-Tolerated Dose (NTD) - Part A 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.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics - AUC Cycle 1 and beyond; and after discontinuation Area under the serum concentration - time curve
Progression-free survival- Part B 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
Antitumor efficacy 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 - tmax Cycle 1 and beyond; and after discontinuation Time to peak (maximum) serum concentration
Pharmacokinetics - T1/2 Cycle 1 and beyond; and after discontinuation Terminal half-life (T1/2)
Pharmacokinetics - CL Cycle 1 and beyond; and after discontinuation Total body clearance of the drug from serum
Pharmacokinetics - Vmax Cycle 1 and beyond; and after discontinuation Volume of distribution at steady-state
Overall Survival - Part B Up to 2 years Measured as the time from the first dose of CC-90002 to death due to any cause.
Pharmacokinetics - Cmax Cycle 1 and beyond; and after discontinuation Maximum observed concentration in serum
Anti-Drug Antibodies (ADAs) Cycle 1 and beyond; and after discontinuation Determine the presence and frequency of anti-drug antibodies
Trial Locations
- Locations (13)
Duran i Reynals Institut Catala d'Oncologia
🇪🇸Barcelona, Spain
Scottsdale Healthcare Research Institute
🇺🇸Scottsdale, Arizona, United States
Hospital Universitario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital de la Fe
🇪🇸Valencia, Spain
Hospital Val d'Hebron
🇪🇸Barcelona, Spain
Hospital Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitari Germans Trias i Pujol Can Ruti
🇪🇸Badalona (Barcelona), Spain
University of California San Francisco
🇺🇸San Francisco, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States