Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03783403
NCT03783403Active, not recruitingPhase 1

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

Celgene31 sites in 7 countries230 target enrollmentStarted: February 1, 2019Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

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 OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Experimental

Intervention: CC-95251 (Drug)

CC-95251

Experimental

Intervention: CC-95251 (Drug)

CC-95251 in combination with rituximab

Experimental

Intervention: CC-95251 (Drug)

CC-95251 in combination with rituximab

Experimental

Intervention: Rituximab (Drug)

CC-95251 in combination with cetuximab

Experimental

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)

Investigators

Sponsor
Celgene
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (31)

Loading locations...

Similar Trials

Terminated
Phase 1
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic SyndromesLeukemia, Myeloid, AcuteMyelodysplastic Syndromes
NCT05168202Bristol-Myers Squibb218
Completed
Phase 1
Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate CancerProstatic Neoplasms
NCT04428788Celgene131
Active, not recruiting
Phase 1
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)Lymphoma, Non-Hodgkin
NCT03930953Celgene438
Withdrawn
Phase 1
EPITHINK: Epigenetic Drug Treatment and Therapeutic Immunotherapy With NKR-2AML, AdultMyelodysplastic Syndromes
NCT03612739Celyad Oncology SA
Active, not recruiting
Phase 1
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)Idiopathic Inflammatory MyopathySystemic Lupus ErythematosusRheumatoid ArthritisSystemic Lupus ErythematosusSystemic SclerosisSystemic SclerosisRheumatoid Arthritis
NCT05869955Juno Therapeutics, Inc., a Bristol-Myers Squibb Company270