A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
Sponsor
Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03783403
Collaborator
(none)
230
54
3
78.8
4.3
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
230 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Feb 1, 2019
Anticipated Primary Completion Date
:
Jun 20, 2024
Anticipated Study Completion Date
:
Aug 25, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CC-95251
|
Drug: CC-95251
Specified dose on specified days
|
| Experimental: CC-95251 in combination with rituximab
|
Drug: CC-95251
Specified dose on specified days
Drug: Rituximab
Specified dose on specified days
|
| Experimental: CC-95251 in combination with cetuximab
|
Drug: CC-95251
Specified dose on specified days
Drug: Cetuximab
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects [18 months]
- Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects [18 months]
- Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria [30 months]
Secondary Outcome Measures
- Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) [72 Months]
- Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR [66 Months]
- 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 [66 Months]
- Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause [66 Months]
- Overall survival (OS): Time from the first dose to death due to any cause [66 Months]
- Pharmacokinetic - Maximum serum concentration of the drug (Cmax) [36 Months]
- Pharmacokinetic - Minimum serum concentration of the drug (Cmin) [36 Months]
- Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) [36 Months]
- Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies [36 Months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Birmingham | Birmingham | Alabama | United States | 35294 |
| 2 | HonorHealth Research Institute | Scottsdale | Arizona | United States | 85258 |
| 3 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
| 4 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
| 5 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 6 | Washington University School Of Medicine | Saint Louis | Missouri | United States | 63110 |
| 7 | NYU Langone Laura and Isaac Perlmutter Cancer Center | New York | New York | United States | 10016 |
| 8 | NYU Langone Laura and Isaac Perlmutter Cancer Center | New York | New York | United States | 10016 |
| 9 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
| 10 | University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
| 11 | University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
| 12 | Providence Cancer Center/Earle A. Chiles Res. Inst. | Portland | Oregon | United States | 97213 |
| 13 | University of Pittsburgh Medical Center - Cancer Pavilion | Pittsburgh | Pennsylvania | United States | 15232 |
| 14 | University of Pittsburgh Medical Center - Cancer Pavilion | Pittsburgh | Pennsylvania | United States | 15232 |
| 15 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
| 16 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
| 17 | The University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 18 | The University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 19 | South Texas Accelerated Research Therapeutics | San Antonio | Texas | United States | 78229 |
| 20 | South Texas Accelerated Research Therapeutics | San Antonio | Texas | United States | 78229 |
| 21 | Austin Health - Austin Hospital | Heidelberg | Victoria | Australia | 3084 |
| 22 | Local Institution - 301 | Heidelberg | Victoria | Australia | 3084 |
| 23 | Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia | 3000 |
| 24 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 25 | Local Institution - 201 | Edmonton | Alberta | Canada | T6G 1Z2 |
| 26 | Princess Margaret Cancer Centre | Toronto | Ontario | Canada | M5G 2M9 |
| 27 | Institut Bergonie | Borddeaux Cedex | France | 33076 | |
| 28 | Local Institution - 402 | Borddeaux Cedex | France | 33076 | |
| 29 | Hôpital Henri Mondor | Creteil | France | 94010 | |
| 30 | Local Institution - 406 | Creteil | France | 94010 | |
| 31 | Unité Lymphoïde - Hématologie 4-IPC4 | Marseille | France | 13009 | |
| 32 | Hotel Dieu CHU Nantes | Nantes Cedex 01 | France | 44093 | |
| 33 | Local Institution - 404 | Nantes Cedex 01 | France | 44093 | |
| 34 | CLCC H BecquerelHematology | Rouen | France | 76038 | |
| 35 | Local Institution - 403 | Rouen | France | 76038 | |
| 36 | Gustave Roussy | Villejuif CEDEX | France | 94805 | |
| 37 | Local Institution - 401 | Villejuif CEDEX | France | 94805 | |
| 38 | Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M | Bologna | Italy | 40138 | |
| 39 | Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale | Napoli, Campania | Italy | 80131 | |
| 40 | Local Institution - 604 | Seoul | Korea, Republic of | 03722 | |
| 41 | Severance Hospital | Seoul | Korea, Republic of | 03722 | |
| 42 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
| 43 | Local Institution - 602 | Seoul | Korea, Republic of | 3080 | |
| 44 | Seoul National University Hospital | Seoul | Korea, Republic of | 3080 | |
| 45 | Asan Medical Center | Seoul | Korea, Republic of | 5505 | |
| 46 | Local Institution - 601 | Seoul | Korea, Republic of | 5505 | |
| 47 | Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | 28040 | |
| 48 | Hospital Universitario Virgen De La Victoria | Malaga | Spain | 29010 | |
| 49 | Local Institution - 502 | Malaga | Spain | 29010 | |
| 50 | Local Institution - 501 | Salamanca | Spain | 37007 | |
| 51 | Universitario de Salamanca - Hospital Clinico | Salamanca | Spain | 37007 | |
| 52 | Derriford Hospital, University Hospitals Plymouth NHS Trust | Crownhill, Plymouth | United Kingdom | PL6 8DH | |
| 53 | Royal Marsden Hospital | London | United Kingdom | SW3 6JJ | |
| 54 | Christie NHS Trust | Manchester | United Kingdom | M20 4BX |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT03783403
Other Study ID Numbers:
- CC-95251-ST-001
- U1111-1224-8251
- NCT03816254
First Posted:
Dec 21, 2018
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Celgene
Additional relevant MeSH terms: