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Closed (no longer recruiting)Last updated: 2 February 2024

This phase I trial is trying to determine the best dose of a drug (CC-95251) given to patients alone or in combination with one of two types of targeted cancer treatments (Rituximab or Cetuximab) in patients with advanced cancers (including advanced types of blood cancer)A Phase 1, 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

Clinical summary

Summary

This is a dose escalation and expansion trial. In the dose escalation phase (Part 1) eligible participants will be allocated to one of three stages. Stage 1 will evaluate escalating doses of CC-95251, administered intravenously (IV), to determine the maximum tolerated dose (MTD), non-tolerated dose (NTD), and/or recommended Phase 2 dose (RP2D). Stage 2 will evaluate escalating doses of CC-95251 in combination with weekly cetuximab, both administered IV, to determine the MTD, NTD, and/or RP2D of CC-95251 plus cetuximab. Stage 3 will evaluate escalating doses of CC-95251 in combination with rituximab, both administered IV, to establish MTD, NTD, and/or RP2D of CC-95251 plus rituximab.

Conditions

This trial is treating patients with advanced cancers (including some types of blood cancer).

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Celgene Corporation

Scientific Title

A Phase 1, 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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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