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