Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 1, Open-Label, Dose Finding Study of CC-95251, A Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

Details

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.

Keywords

Neoplasms Antibody CC-95251 SIRPα Advanced Solid Cancers Advanced Hematologic Cancers Hematologic Neoplasms Antibodies Immunoglobulins Rituximab Antibodies, Monoclonal Cetuximab CC-95251 alone

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subject must understand and voluntarily sign an informed consent form (ICF).
  2. Subject (male or female) is ≥ 18 years of age at the time of signing the ICF.
  3. 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.
  4. 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.
  5. Subject has an ECOG PS of 0 or 1.
  6. Subjects must exhibit acceptable hematopoietic, liver, renal, and coagulation function as assessed by laboratory tests.
  7. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

You CAN'T join if...

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

Locations

  • Moores UCSD Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • HonorHealth Research Institute accepting new patients
    Scottsdale Arizona 85258 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT03783403
Phase
Phase 1
Study Type
Interventional
Last Updated