Clinical trial NCT03783403: A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Antibody
CC-95251
SIRPα
Advanced Solid Cancers
Advanced Hematologic Cancers
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-12-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
timeFrame: 18 months
measure: Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
timeFrame: 18 months
measure: Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
timeFrame: 30 months
Secondary outcomes:
measure: Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)
timeFrame: 72 Months
measure: Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR
timeFrame: 66 Months
measure: 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
timeFrame: 66 Months
measure: Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause
timeFrame: 66 Months
measure: Overall survival (OS): Time from the first dose to death due to any cause
timeFrame: 66 Months
measure: Pharmacokinetic - Maximum serum concentration of the drug (Cmax)
timeFrame: 36 Months
measure: Pharmacokinetic - Minimum serum concentration of the drug (Cmin)
timeFrame: 36 Months
measure: Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)
timeFrame: 36 Months
measure: Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies
timeFrame: 36 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 105
state: Alabama
city: Scottsdale
country: United States
facility: Local Institution - 101
state: Arizona
city: Sacramento
country: United States
facility: Local Institution - 112
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers, LLP [Aurora-COAU]
state: Colorado
city: Saint Louis
country: United States
facility: Local Institution - 115
state: Missouri
city: New York
country: United States
facility: Local Institution - 110
state: New York
city: Charlotte
country: United States
facility: Local Institution - 109
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution - 106
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 113
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 107
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 102
state: Tennessee
city: Houston
country: United States
facility: Local Institution - 108
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 103
state: Texas
city: Heidelberg
country: Australia
facility: Local Institution - 301
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 303
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution - 201
state: Alberta
city: Toronto
country: Canada
facility: Local Institution - 202
state: Ontario
city: Borddeaux Cedex
country: France
facility: Local Institution - 402
city: Creteil
country: France
facility: Local Institution - 406
city: Marseille
country: France
facility: Local Institution - 405
city: Nantes Cedex 01
country: France
facility: Local Institution - 404
city: Rouen
country: France
facility: Local Institution - 403
city: Villejuif CEDEX
country: France
facility: Local Institution - 401
city: Seoul
country: Korea, Republic of
facility: Local Institution - 604
city: Seoul
country: Korea, Republic of
facility: Local Institution - 603
city: Seoul
country: Korea, Republic of
facility: Local Institution - 602
city: Seoul
country: Korea, Republic of
facility: Local Institution - 601
city: Madrid
country: Spain
facility: Local Institution - 504
city: Malaga
country: Spain
facility: Local Institution - 502
city: Salamanca
country: Spain
facility: Local Institution - 501
city: Manchester
country: United Kingdom
facility: Local Institution - 802
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: