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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

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

Details

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.

Keywords

Hematologic Neoplasms CC-90002 Monoclonal Antibody CD47 Advanced Solid Cancers Hematologic Cancers Rituximab

Eligibility

You can join if…

Open to people ages 18 years and up

    1. 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 or refractory CD20-positive NHL subjects only.
    2. At least one site of measurable disease in subjects with solid tumors and NHL.
    3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
    4. 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

You CAN'T join if...

  1. High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
  2. High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
  3. Symptomatic central nervous system involvement.
  4. Impaired cardiac function or clinically significant cardiac disease.
  5. Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002.
  6. Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
  7. Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
  8. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
  9. Major surgery ≤ 2 weeks prior to starting CC-90002.
  10. Pregnant or nursing females.
  11. Known HIV infection.
  12. Known chronic hepatitis B or C (HBV/HCV) infection.
  13. Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
  14. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
  15. History of concurrent second cancers requiring active, ongoing systemic treatment.

Locations

  • Scottsdale Healthcare Research Institute accepting new patients
    Scottsdale, Arizona, 85258, United States
  • University of Arizona Cancer Center not yet accepting patients
    Tucson, Arizona, 85724, United States
  • South Texas Accelerated Research Therapeutics accepting new patients
    San Antonio, Texas, 78229, United States
  • Yale University School of Medicine not yet accepting patients
    New Haven, Connecticut, 06520-8073, United States
  • Hospital Universitari Germans Trias i Pujol Can Ruti accepting new patients
    Badalona (Barcelona), 08916, Spain
  • Hospital Vall d'Hebron accepting new patients
    Barcelona, 08035, Spain
  • Hospital Universitario Fundacion Jimenez Diaz accepting new patients
    Madrid, 28040, Spain
  • Hospital Universitario de Salamanca accepting new patients
    Salamanca, 37007, Spain

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT02367196
Phase
Phase 1
Lead Scientist
Pamela Munster
Study Type
Interventional
Last Updated
May 1, 2017
I’m interested in this study!