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

Status: Active

Description

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-95251 in subjects with advanced cancers.

Eligibility Criteria

Inclusion Criteria

  • Subject must understand and voluntarily sign an informed consent form (ICF).
  • Subject (male or female) is ≥ 18 years of age at the time of signing the ICF.
  • Subject must have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors.
  • Subject must have at least one site of measurable disease as determined by RECIST v1.1. NHL subjects must have bi-dimensionally measurable disease on cross sectional imaging by CT or MRI as defined by Lugano/IWG criteria.
  • Subject has an ECOG PS of 0 or 1.
  • Subjects must exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

  • Subject has received prior investigational therapy directed at CD47 or SIRPα.
  • Subject has cancer with symptomatic central nervous system involvement.
  • Subject is on chronic systemic immunosuppressive therapy or corticosteroids.
  • Subjects with a history of clinically significant cardiac disease within the previous 6 months.
  • Subject had a prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-95251, whichever is shorter.
  • Subject had major surgery ≤ 2 weeks prior to starting CC-95251.
  • Subject is a pregnant or lactating female.
  • Subject has known human immunodeficiency virus (HIV) infection.
  • Subject has known chronic, active hepatitis B or C (HBV/HCV) infection.
  • Ongoing treatment with chronic, therapeutic dosing of anti-coagulants.
  • History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
  • History of concurrent second cancers requiring active, ongoing systemic treatment.
  • For subjects receiving cetuximab, known history of cetuximab intolerance.

Locations & Contacts

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Trial Objectives and Outline

Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B & Part C), first-in-human clinical study of CC-95251 in subjects with advanced solid & hematologic cancers. The dose escalation part (Part A) of the study will be conducted in three stages. Stage 1 will evaluate the safety and tolerability of escalating doses of CC-95251, administered IV, to determine the maximum tolerated dose (MTD), non-tolerated dose (NTD), and/or recommended Phase 2 dose (RP2D) of CC-95251. Stage 2 will evaluate the safety and tolerability of escalating doses of CC-95251 in combination with weekly cetuximab, both administered IV, to determine the MTD, NTD, and/or RP2D of CC-95251 plus cetuximab. Stage 3 will evaluate the safety and tolerability of escalating doses of CC-95251 in combination with rituximab, both administered IV, to establish MTD, NTD, and/or RP2D of CC-95251 plus rituximab.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Celgene

Trial IDs

Primary ID CC-95251-ST-001
Secondary IDs NCI-2019-02662, U1111-1224-8251
Clinicaltrials.gov ID NCT03783403