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

NCT03783403 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CC-95251-ST-001U1111-1224-8251
• Study Type: interventional
• Target: 206
• Locations: 7 countries
• Sites: 31

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.

Conditions

Neoplasms

Keywords

Antibody; CC-95251; SIRPα; Advanced Solid Cancers; Advanced Hematologic Cancers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (3)

CC-95251

EXPERIMENTAL

Drug: CC-95251

CC-95251 in combination with rituximab

EXPERIMENTAL

Drug: CC-95251; Drug: Rituximab

CC-95251 in combination with cetuximab

EXPERIMENTAL

Drug: CC-95251; Drug: Cetuximab

Interventions

CC-95251 DRUG

Specified dose on specified days

CC-95251; CC-95251 in combination with cetuximab; CC-95251 in combination with rituximab

Rituximab DRUG

Specified dose on specified days

CC-95251 in combination with rituximab

Cetuximab DRUG

Specified dose on specified days

CC-95251 in combination with cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (31)

Local Institution - 105

Birmingham, Alabama, 35294, United States

Location

Local Institution - 101

Scottsdale, Arizona, 85258, United States

Location

Local Institution - 112

Sacramento, California, 95817, United States

Location

Rocky Mountain Cancer Centers, LLP [Aurora-COAU]

Aurora, Colorado, 80012, United States

Location

Local Institution - 115

St Louis, Missouri, 63110, United States

Location

Local Institution - 110

New York, New York, 10016, United States

Location

Local Institution - 109

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 106

Oklahoma City, Oklahoma, 73104, United States

Location

Local Institution - 113

Portland, Oregon, 97213, United States

Location

Local Institution - 107

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 102

Nashville, Tennessee, 37203-1625, United States

Location

Local Institution - 108

Houston, Texas, 77030, United States

Location

Local Institution - 103

San Antonio, Texas, 78229, United States

Location

Local Institution - 301

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 303

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 201

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 202

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 402

Borddeaux Cedex, 33076, France

Location

Local Institution - 406

Créteil, 94010, France

Location

Local Institution - 405

Marseille, 13009, France

Location

Local Institution - 404

Nantes, 44093, France

Location

Local Institution - 403

Rouen, 76038, France

Location

Local Institution - 401

Villejuif, 94805, France

Location

Local Institution - 604

Seoul, 03722, South Korea

Location

Local Institution - 603

Seoul, 06351, South Korea

Location

Local Institution - 602

Seoul, 3080, South Korea

Location

Local Institution - 601

Seoul, 5505, South Korea

Location

Local Institution - 504

Madrid, 28040, Spain

Location

Local Institution - 502

Málaga, 29010, Spain

Location

Local Institution - 501

Salamanca, 37007, Spain

Location

Local Institution - 802

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• Chan H, Trout CV, Mikolon D, Adams P, Guzman R, Mavrommatis K, Abbasian M, Hadjivassiliou H, Dearth L, Fox BA, Sivakumar P, Cho H, Hariharan K. Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPalpha That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies. Cancer Res Commun. 2024 Feb 22;4(2):505-515. doi: 10.1158/2767-9764.CRC-23-0634.

  PMID: 38319147 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Neoplasms

Interventions

Rituximab; Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: March 1, 2019
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GB (1); AU (2); CA (2); US (13); KR (4); ES (3); FR (6)