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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03783403




Registration number
NCT03783403
Ethics application status
Date submitted
19/12/2018
Date registered
21/12/2018
Date last updated
1/12/2023

Titles & IDs
Public title
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPa, in Participants With Advanced Solid and Hematologic Cancers
Scientific title
A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
Secondary ID [1] 0 0
U1111-1224-8251
Secondary ID [2] 0 0
CC-95251-ST-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-95251
Treatment: Drugs - Rituximab
Treatment: Drugs - Cetuximab

Experimental: CC-95251 -

Experimental: CC-95251 in combination with rituximab -

Experimental: CC-95251 in combination with cetuximab -


Treatment: Drugs: CC-95251
Specified dose on specified days

Treatment: Drugs: Rituximab
Specified dose on specified days

Treatment: Drugs: Cetuximab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Timepoint [3] 0 0
30 months
Secondary outcome [1] 0 0
Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Timepoint [1] 0 0
72 Months
Secondary outcome [2] 0 0
Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
Timepoint [2] 0 0
66 Months
Secondary outcome [3] 0 0
Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented
Timepoint [3] 0 0
66 Months
Secondary outcome [4] 0 0
Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
Timepoint [4] 0 0
66 Months
Secondary outcome [5] 0 0
Overall survival (OS): Time from the first dose to death due to any cause
Timepoint [5] 0 0
66 Months
Secondary outcome [6] 0 0
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Timepoint [6] 0 0
36 Months
Secondary outcome [7] 0 0
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
Timepoint [7] 0 0
36 Months
Secondary outcome [8] 0 0
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Timepoint [8] 0 0
36 Months
Secondary outcome [9] 0 0
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
Timepoint [9] 0 0
36 Months

Eligibility
Key inclusion criteria
- Progressed on standard anticancer therapy or for whom no other approved conventional
therapy exists and have histological or cytological confirmation of advanced
unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell
carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse
large B cell lymphoma, or follicular lymphoma

- Solid tumors must have at least one site of measurable disease as determined by RECIST
v1.1

- Eastern cooperative oncology group performance status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- High-grade lymphomas (Burkitt's or lymphoblastic)

- Has cancer with symptomatic central nervous system (CNS) involvement

- History of class III or IV congestive heart failure (CHF) or severe non-ischemic
cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia
within the previous 6 months

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/08/2024
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - 301 - Heidelberg
Recruitment hospital [2] 0 0
Local Institution - 303 - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
France
State/province [15] 0 0
Borddeaux Cedex
Country [16] 0 0
France
State/province [16] 0 0
Creteil
Country [17] 0 0
France
State/province [17] 0 0
Marseille
Country [18] 0 0
France
State/province [18] 0 0
Nantes Cedex 01
Country [19] 0 0
France
State/province [19] 0 0
Rouen
Country [20] 0 0
France
State/province [20] 0 0
Villejuif CEDEX
Country [21] 0 0
Italy
State/province [21] 0 0
Bologna
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli, Campania
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Malaga
Country [26] 0 0
Spain
State/province [26] 0 0
Salamanca
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical
activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in
participants with advanced solid and hematologic cancers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03783403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03783403