Neoplasms
Conditions
Keywords
Antibody, CC-95251, SIRPα, Advanced Solid Cancers, Advanced Hematologic Cancers
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.
Interventions
DRUGCC-95251
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGCetuximab
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR) | 72 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 |
| Pharmacokinetic - Minimum serum concentration of the drug (Cmin) | 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 |
| 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 |
Countries
Australia, Canada, France, South Korea, Spain, United Kingdom, United States
Outcome results
None listed