A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:March 12, 2015
End Date:May 28, 2021
Contact:Associate Director Clinical Trial Disclosure
Email:clinicaltrialdisclosure@celgene.com
Phone:1-888-260-1599

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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

CC-90002-ST -001 is an open-label, Phase 1, dose escalation and expansion clinical study in
subjects advanced, refractory solid and hematologic cancers.

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.

Part B dose escalation will explore escalating doses of CC-90002 in combination with
rituximab and expansion in combination with rituximab in subjects with CD20-positive NHL.

Inclusion Criteria:

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
and/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.

5. 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

Exclusion Criteria:

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 (Part A
only).

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, active 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.

concurrent second cancers requiring active, ongoing systemic treatment.
We found this trial at
6
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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