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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Celgene
- Enrollment
- 230
- Locations
- 31
- Primary Endpoint
- Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Study Overview
Brief Summary
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.
Detailed Description
This is a test.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CC-95251 in combination with cetuximab
Intervention: CC-95251 (Drug)
CC-95251
Intervention: CC-95251 (Drug)
CC-95251 in combination with rituximab
Intervention: CC-95251 (Drug)
CC-95251 in combination with rituximab
Intervention: Rituximab (Drug)
CC-95251 in combination with cetuximab
Intervention: Cetuximab (Drug)
Outcomes
Primary Outcomes
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
Time Frame: 18 months
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
Time Frame: 18 months
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
Time Frame: 30 months
Secondary Outcomes
- Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)(72 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)
- 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)
- Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause(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)
