Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
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.
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.
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
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