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Trial ID CC-95251-ST-001  |   NCT03783403

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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
    1. Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
      1. Eastern cooperative oncology group performance status of 0 or 1

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • High-grade lymphomas (Burkitt's or lymphoblastic)
          1. Has cancer with symptomatic central nervous system (CNS) involvement
            1. 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
              Additional Information *

              Treatment Options

              Study Arms

              ASSIGNED INTERVENTION

              Study Arms

              Experimental: CC-95251

              ASSIGNED INTERVENTION
              • Drug: CC-95251

              Study Arms

              Experimental: CC-95251 in combination with cetuximab

              ASSIGNED INTERVENTION
              • Drug: CC-95251, Cetuximab

              Study Arms

              Experimental: CC-95251 in combination with rituximab

              ASSIGNED INTERVENTION
              • Drug: CC-95251, Rituximab

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