Back to resultsA Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
Primary Purpose
Hematologic Neoplasms
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-90002
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Neoplasms focused on measuring CC-90002, Monoclonal, Antibody, CD47, Advanced, Solid Cancers, Hematologic Cancers
Eligibility Criteria
Inclusion Criteria:
- 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.
- At least one site of measurable disease in subjects with solid tumors and NHL.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
- 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:
- High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
- High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
- Symptomatic central nervous system involvement.
- Impaired cardiac function or clinically significant cardiac disease.
- Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
- Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
- Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
- Major surgery ≤ 2 weeks prior to starting CC-90002.
- Pregnant or nursing females.
- Known HIV infection.
- Known chronic, active hepatitis B or C (HBV/HCV) infection.
- Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- History of concurrent second cancers requiring active, ongoing systemic treatment.
concurrent second cancers requiring active, ongoing systemic treatment.
Sites / Locations
- Scottsdale Healthcare Research Institute
- University of Arizona Cancer Center
- University of California San Francisco
- Yale University School of Medicine
- South Texas Accelerated Research Therapeutics
- Hospital Universitari Germans Trias i Pujol Can Ruti
- Hospital Val d'Hebron
- Duran i Reynals Institut Catala d'Oncologia
- Hospital Universitario Fundacion Jimenez Diaz
- Hospital 12 de Octubre
- Hospital Universitario de Salamanca
- Hospital Marques de Valdecilla
- Hospital de la Fe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: CC-90002
Part B: CC-90002 with Rituximab
Arm Description
CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
Outcomes
Primary Outcome Measures
Dose-Limiting Toxicity (DLT)
Number of participants with a DLT
Non-Tolerated Dose (NTD) - Part A
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
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
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
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.
Secondary Outcome Measures
Antitumor efficacy
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
Maximum observed concentration in serum
Pharmacokinetics - AUC
Area under the serum concentration - time curve
Pharmacokinetics - tmax
Time to peak (maximum) serum concentration
Pharmacokinetics - T1/2
Terminal half-life (T1/2)
Pharmacokinetics - CL
Total body clearance of the drug from serum
Pharmacokinetics - Vmax
Volume of distribution at steady-state
Anti-Drug Antibodies (ADAs)
Determine the presence and frequency of anti-drug antibodies
Overall Survival - Part B
Measured as the time from the first dose of CC-90002 to death due to any cause.
Progression-free survival- Part B
Defined as the time from the first dose of CC-90002 to the first occurrence of disease progression or death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02367196
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2015 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
December 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
CC-90002, Monoclonal, Antibody, CD47, Advanced, Solid Cancers, Hematologic Cancers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: CC-90002
Arm Type
Experimental
Arm Description
CC-90002 will be given by intravenous (IV) infusion on a 28 day cycle
Arm Title
Part B: CC-90002 with Rituximab
Arm Type
Experimental
Arm Description
CC-90002 in combination with Rituximab will be given by intravenous (IV) infusion on a 28 day cycle in subjects with CD20-positive NHL
Intervention Type
Drug
Intervention Name(s)
CC-90002
Intervention Type
Drug
Intervention Name(s)
Rituximab
Primary Outcome Measure Information:
Title
Dose-Limiting Toxicity (DLT)
Description
Number of participants with a DLT
Time Frame
Up to 18 months
Title
Non-Tolerated Dose (NTD) - Part A
Description
Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
Time Frame
Up to 18 months
Title
Maximum Tolerated Dose (MTD) - Part A
Description
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.
Time Frame
Up to 18 months
Title
Non-Tolerated Dose (NTD) - Part B
Description
Dose at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1.
Time Frame
Up to 24 months
Title
Maximum Tolerated Dose (MTD) - Part B
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Antitumor efficacy
Description
Determined by response rates of each tumor type using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and other tumor-appropriate response criteria.
Time Frame
Up to 36 months
Title
Pharmacokinetics - Cmax
Description
Maximum observed concentration in serum
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Pharmacokinetics - AUC
Description
Area under the serum concentration - time curve
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Pharmacokinetics - tmax
Description
Time to peak (maximum) serum concentration
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Pharmacokinetics - T1/2
Description
Terminal half-life (T1/2)
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Pharmacokinetics - CL
Description
Total body clearance of the drug from serum
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Pharmacokinetics - Vmax
Description
Volume of distribution at steady-state
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Anti-Drug Antibodies (ADAs)
Description
Determine the presence and frequency of anti-drug antibodies
Time Frame
Cycle 1 and beyond; and after discontinuation
Title
Overall Survival - Part B
Description
Measured as the time from the first dose of CC-90002 to death due to any cause.
Time Frame
Up to 2 years
Title
Progression-free survival- Part B
Description
Defined as the time from the first dose of CC-90002 to the first occurrence of disease progression or death from any cause
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
At least one site of measurable disease in subjects with solid tumors and NHL.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria.
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:
High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden.
Symptomatic central nervous system involvement.
Impaired cardiac function or clinically significant cardiac disease.
Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only).
Prior autologous stem cell transplant ≤ 3 months prior to starting CC-90002.
Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90002.
Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter.
Major surgery ≤ 2 weeks prior to starting CC-90002.
Pregnant or nursing females.
Known HIV infection.
Known chronic, active hepatitis B or C (HBV/HCV) infection.
Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
History of concurrent second cancers requiring active, ongoing systemic treatment.
concurrent second cancers requiring active, ongoing systemic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Burgess, MD, PhD
Organizational Affiliation
Celgene
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Healthcare Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-1270
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8073
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hospital Universitari Germans Trias i Pujol Can Ruti
City
Badalona (Barcelona)
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Val d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Duran i Reynals Institut Catala d'Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital de la Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
34247273
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.
Results Reference
derived
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A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers
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