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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: CC-95251
* Drug: Rituximab
* Drug: Cetuximab


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-95251<br> | Drug: CC-95251<br>* Specified dose on specified days<br>|
| Experimental: CC-95251 in combination with rituximab<br> | Drug: CC-95251<br>* Specified dose on specified days<br>Drug: Rituximab<br>* Specified dose on specified days<br>|
| Experimental: CC-95251 in combination with cetuximab<br> | Drug: CC-95251<br>* Specified dose on specified days<br>Drug: Cetuximab<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects |  | 18 months | 
| Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects |  | 18 months | 
| Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria |  | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) |  | 72 Months | 
| Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR |  | 66 Months | 
| Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented |  | 66 Months | 
| Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause |  | 66 Months | 
| Overall survival (OS): Time from the first dose to death due to any cause |  | 66 Months | 
| Pharmacokinetic - Maximum serum concentration of the drug (Cmax) |  | 36 Months | 
| Pharmacokinetic - Minimum serum concentration of the drug (Cmin) |  | 36 Months | 
| Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC) |  | 36 Months | 
| Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies |  | 36 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibody, CC-95251, SIRPα, Advanced Solid Cancers, Advanced Hematologic Cancers