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

Celgene

Status and phase: Terminated; Phase 1

Conditions: Neoplasms

Treatments: Drug: CC-95251; Drug: Cetuximab; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03783403

U1111-1224-8251 (Registry Identifier)

CC-95251-ST-001

Details and patient eligibility

About

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.

Full description

This is a test.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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206 participants in 3 patient groups

CC-95251

Experimental group

Treatment:

Drug: CC-95251

CC-95251 in combination with rituximab

Experimental group

Treatment:

Drug: Rituximab

Drug: CC-95251

CC-95251 in combination with cetuximab

Experimental group

Treatment:

Drug: Cetuximab

Drug: CC-95251