A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03783403 Recruiting December 21, 2018 June 16, 2022

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: Neoplasms
Intervention/treatment: Drug: CC-95251
Drug: Rituximab
Drug: Cetuximab
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 230 participants
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
Actual Study Start Date: February 2019
Estimated Primary Completion Date: June 2024
Estimated Study Completion Date: August 2025

Arms and interventions
Arm Intervention/treatment
Experimental: CC-95251
Drug: CC-95251
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
Experimental: CC-95251 in combination with rituximab
Drug: CC-95251
Specified dose on specified days

Drug: Rituximab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects [ Time Frame: 18 months ]
2. Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects [ Time Frame: 18 months ]
3. Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria [ Time Frame: 30 months ]
Secondary Outcome Measures: 1. Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) [ Time Frame: 72 Months ]
2. 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 ]
3. 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 ]
4. 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 ]
5. Overall survival (OS): Time from the first dose to death due to any cause [ Time Frame: 66 Months ]
6. Pharmacokinetic - Maximum serum concentration of the drug (Cmax) [ Time Frame: 36 Months ]
7. Pharmacokinetic - Minimum serum concentration of the drug (Cmin) [ Time Frame: 36 Months ]
8. Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) [ Time Frame: 36 Months ]
9. Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies [ Time Frame: 36 Months ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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


Contacts and Locations
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations
United States, Alabama University of Alabama Birmingham Birmingham
United States, Arizona HonorHealth Research Institute Scottsdale
United States, California UC Davis Medical Center Sacramento
United States, California UC Davis Medical Center Sacramento
United States, Missouri Washington University School of Medicine Saint Louis
United States, Missouri Washington University School Of Medicine Saint Louis
United States, New York NYU Langone Laura and Isaac Perlmutter Cancer Center New York
United States, New York NYU Langone Laura and Isaac Perlmutter Cancer Center New York
United States, North Carolina Levine Cancer Institute Charlotte
United States, Oklahoma University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City
United States, Oklahoma University of Oklahoma Peggy and Charles Stephenson Cancer Center Oklahoma City
United States, Oregon Providence Cancer Center/Earle A. Chiles Res. Inst. Portland
United States, Pennsylvania University of Pittsburgh Medical Center - Cancer Pavilion Pittsburgh
United States, Pennsylvania University of Pittsburgh Medical Center - Cancer Pavilion Pittsburgh
United States, Tennessee Tennessee Oncology Nashville
United States, Tennessee Tennessee Oncology Nashville
United States, Texas The University of Texas - MD Anderson Cancer Center Houston
United States, Texas The University of Texas - MD Anderson Cancer Center Houston
United States, Texas South Texas Accelerated Research Therapeutics San Antonio
United States, Texas South Texas Accelerated Research Therapeutics San Antonio
Australia, Victoria Austin Health - Austin Hospital Heidelberg
Australia, Victoria Local Institution - 301 Heidelberg
Australia, Victoria Peter MacCallum Cancer Centre Melbourne
Canada, Alberta Cross Cancer Institute Edmonton
Canada, Alberta Local Institution - 201 Edmonton
Canada, Ontario Princess Margaret Cancer Centre Toronto
France Institut Bergonie Borddeaux Cedex
France Local Institution - 402 Borddeaux Cedex
France Hôpital Henri Mondor Creteil
France Local Institution - 406 Creteil
France Unité Lymphoïde - Hématologie 4-IPC4 Marseille
France Hotel Dieu CHU Nantes Nantes Cedex 01
France Local Institution - 404 Nantes Cedex 01
France CLCC H BecquerelHematology Rouen
France Local Institution - 403 Rouen
France Gustave Roussy Villejuif CEDEX
France Local Institution - 401 Villejuif CEDEX
Italy Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M Bologna
Italy Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Napoli, Campania
Korea, Republic of Local Institution - 604 Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Local Institution - 602 Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Local Institution - 601 Seoul
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario Virgen De La Victoria Malaga
Spain Local Institution - 502 Malaga
Spain Local Institution - 501 Salamanca
Spain Universitario de Salamanca - Hospital Clinico Salamanca
United Kingdom Derriford Hospital, University Hospitals Plymouth NHS Trust Crownhill, Plymouth
United Kingdom Royal Marsden Hospital London
United Kingdom Christie NHS Trust Manchester
Sponsors and Collaborators
Celgene
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Celgene
ClinicalTrials.gov Identifier : NCT03783403     
Other Study ID Numbers : CC-95251-ST-001, NCT03816254, U1111-1224-8251
First Posted : December 21, 2018
Last Update Posted : June 16, 2022
Last Verified : June 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene: Antibody
CC-95251
SIRPα
Advanced Solid Cancers
Advanced Hematologic Cancers
Additional relevant MeSH terms :
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases