Clinical trial NCT02367196: A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematologic Neoplasms
Keywords: CC-90002
Monoclonal
Antibody
CD47
Advanced
Solid Cancers
Hematologic Cancers
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose-Limiting Toxicity (DLT)
timeFrame: Up to 18 months
measure: Non-Tolerated Dose (NTD) - Part A
timeFrame: Up to 18 months
measure: Maximum Tolerated Dose (MTD) - Part A
timeFrame: Up to 18 months
measure: Non-Tolerated Dose (NTD) - Part B
timeFrame: Up to 24 months
measure: Maximum Tolerated Dose (MTD) - Part B
timeFrame: Up to 24 months
Secondary outcomes:
measure: Antitumor efficacy
timeFrame: Up to 36 months
measure: Pharmacokinetics - Cmax
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Pharmacokinetics - AUC
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Pharmacokinetics - tmax
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Pharmacokinetics - T1/2
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Pharmacokinetics - CL
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Pharmacokinetics - Vmax
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Anti-Drug Antibodies (ADAs)
timeFrame: Cycle 1 and beyond; and after discontinuation
measure: Overall Survival - Part B
timeFrame: Up to 2 years
measure: Progression-free survival- Part B
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: Badalona (Barcelona)
country: Spain
facility: Hospital Universitari Germans Trias i Pujol Can Ruti
city: Barcelona
country: Spain
facility: Hospital Val d'Hebron
city: Barcelona
country: Spain
facility: Duran i Reynals Institut Catala d'Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital de la Fe
Study officials:
affiliation: Celgene
name: Michael Burgess, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Narla RK, Modi H, Bauer D, Abbasian M, Leisten J, Piccotti JR, Kopytek S, Eckelman BP, Deveraux Q, Timmer J, Zhu D, Wong L, Escoubet L, Raymon HK, Hariharan K. Modulation of CD47-SIRPalpha innate immune checkpoint axis with Fc-function detuned anti-CD47 therapeutic antibody. Cancer Immunol Immunother. 2022 Feb;71(2):473-489. doi: 10.1007/s00262-021-03010-6. Epub 2021 Jul 10.