Clinical Trial: A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
Brief Summary: CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in subjects advanced, refractory solid and hematologic cancers.
Detailed Summary: 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. Following completion of Part A, CC-90002 in combination with rituximab will be administered in subjects with CD20-positive non-Hodgkin's lymphoma (NHL) in Part B dose escalation and expansion phase.
Sponsor: Celgene
Current Primary Outcome:
- 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.
Original Primary Outcome:
- Number of participants with a Dose‐Limiting Toxicity (DLT) [ Time Frame: Up to 18 months ]
- Non-Tolerated Dose (NTD) [ 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) [ 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.
Current Secondary Outcome:
- 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
Original Secondary Outcome:
- 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 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Maximum observed concentration in plasma
- Pharmacokinetics - AUC [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Area under the plasma concentration‐time curve
- Pharmacokinetics - tmax [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Time to peak (maximum) plasma concentration
- Pharmacokinetics ‐ T1/2 [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Terminal half‐life (T1/2)
- Pharmacokinetics - CL [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Total body clearance of the drug from the plasma
- Pharmacokinetics - Vmax [ Time Frame: Cycle 1 Days 1, 2, 4, 8, 9, 15, 22, 23, 25; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Volume of distribution at steady-state
- Anti-Drug Antibodies (ADAs) [ Time Frame: Cycle 1 Days 1, 8, 15, 22; Cycle 2 and beyond Days 1, 15; and after discontinuation. ]Determine the presence and frequency of anti-drug antibodies
Information By: Celgene
Dates:
Date Received: February 13, 2015
Date Started: March 30, 2015
Date Completion: January 21, 2018
Last Updated: May 9, 2017
Last Verified: May 2017