A Phase I, Open-Label, Dose Finding Study of CC-95251, A Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

Study Identifier:
CC-95251-ST-001
CT.gov Identifier:
NCT03783403
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

Considering participating in a START clinical trial?

Get Started

Study Summary

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.

To evaluate the safety and tolerability of escalating doses of CC‑95251 + ritux and to define the maximum tolerated dose (MTD) and/or recommended phase 2 dose for the combination in patients (pts) with CD20+ R/R NHL

To evaluate BMS-986351 alone or in combination with other therapeutic antibodies in patients with advanced cancer

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Neoplasms
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18 - 84 Years
    Study Drug
  • Drug: Phase 1, dose escalation (Part A) and expansion (Part B & Part C)
    • Read More
  • Drug: Pts were treated in 28-day cycles (C) with CC-95251 administered intravenously at doses of 3, 10, or 20 mg/kg every week (QW) and with ritux 375 mg/m2on days (D) 1, 8, 15, and 22 of C1, D1 of C2-5, and D1 of every other cycle C6-24 until disease progression or unacceptable toxicity.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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
    • Patients with CD20+ NHL who had progressed on standard anticancer therapy or for whom no approved conventional therapy was available were eligible for inclusion.
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Neoplasms