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A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

Primary Purpose

Neoplasms

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-95251
Rituximab
Cetuximab
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Antibody, CC-95251, SIRPα, Advanced Solid Cancers, Advanced Hematologic Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Local Institution - 105
  • Local Institution - 101
  • Local Institution - 112
  • Local Institution - 115
  • Local Institution - 110
  • Local Institution - 109
  • Local Institution - 106
  • Local Institution - 113
  • Local Institution - 107
  • Local Institution - 102
  • Local Institution - 108
  • Local Institution - 103
  • Local Institution - 301
  • Local Institution - 303
  • Local Institution - 201
  • Local Institution - 202
  • Local Institution - 402
  • Local Institution - 406
  • Local Institution - 405
  • Local Institution - 404
  • Local Institution - 403
  • Local Institution - 401
  • Local Institution - 701
  • Local Institution - 702
  • Local Institution - 604
  • Local Institution - 603
  • Local Institution - 602
  • Local Institution - 601
  • Local Institution - 504
  • Local Institution - 502
  • Local Institution - 501
  • Local Institution - 802

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CC-95251

CC-95251 in combination with rituximab

CC-95251 in combination with cetuximab

Arm Description

Outcomes

Primary Outcome Measures

Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria

Secondary Outcome Measures

Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
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
Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
Overall survival (OS): Time from the first dose to death due to any cause
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies

Full Information

First Posted
December 19, 2018
Last Updated
September 27, 2023
Sponsor
Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT03783403
Brief Title
A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
Official Title
A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 20, 2024 (Anticipated)
Study Completion Date
August 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Antibody, CC-95251, SIRPα, Advanced Solid Cancers, Advanced Hematologic Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CC-95251
Arm Type
Experimental
Arm Title
CC-95251 in combination with rituximab
Arm Type
Experimental
Arm Title
CC-95251 in combination with cetuximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-95251
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Time Frame
18 months
Title
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Time Frame
18 months
Title
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
Time Frame
72 Months
Title
Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
Time Frame
66 Months
Title
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
Time Frame
66 Months
Title
Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
Time Frame
66 Months
Title
Overall survival (OS): Time from the first dose to death due to any cause
Time Frame
66 Months
Title
Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
Time Frame
36 Months
Title
Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
Time Frame
36 Months
Title
Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
Time Frame
36 Months
Title
Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
Time Frame
36 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 105
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Local Institution - 101
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Local Institution - 112
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Local Institution - 115
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 110
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 109
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 106
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution - 113
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Local Institution - 107
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 102
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1625
Country
United States
Facility Name
Local Institution - 108
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 103
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution - 301
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 303
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution - 201
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 202
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 402
City
Borddeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution - 406
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution - 405
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Local Institution - 404
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 403
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Local Institution - 401
City
Villejuif CEDEX
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution - 701
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution - 702
City
Napoli, Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 604
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 603
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 602
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Local Institution - 601
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Local Institution - 504
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 502
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 501
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution - 802
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

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