Optimise viewing for

Toggle between patient and health professional views. The patient version is simplified to help people easily find suitable trials, while the professional view provides full detail.

No longer recruiting (closed or complete)Last updated: 15 November 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

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 people with advanced cancers (including some types of blood cancer)

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 had treatment, but your cancer has come back (relapsed or recurrent).
  • 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.

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 are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

No longer recruiting (closed or complete) hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

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

Get Support

Peer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Peer Connect

Contact cancer support

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.

Get support

Multilingual information

Learn more about clinical trials through this collection of resources in languages other than English.

View information