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A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy study of STRO-001, an anti-CD74 Antibody Drug Conjugate, in Patients with Advanced B-Cell Malignancies

Clinical Trial Details

First-in-human phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 2 weeks.

Key Eligibility: 

Inclusion Criteria

  • Confirmation of diagnosis
  • Relapsed or relapsed/refractory disease
  • Age ≥ 18 years
  • ECOG performance status (0-2)
  • Life expectancy greater than 3 months
  • Adequate bone marrow and renal functions
  • Ability to comply with treatment, PK and test schedules
  • At least one measurable lesion (NHL subjects) 

Exclusion Criteria

  • Active plasma cell leukemia and/or leukemic manifestations of lymphoma
  • Known amyloidosis (myeloma subjects)
  • Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects)
  • T-cell malignancy
  • Sensory or motor neuropathy ≥ grade 2
  • Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
  • Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Subjects may be using topical or inhaled corticosteroids
  • Clinically significant cardiac disease
  • Significant concurrent, uncontrolled medical condition
  • History or clinical signs of meningeal or active CNS involvement
  • Known severe chronic obstructive pulmonary disease or asthma
  • History of significant cerebrovascular disease
  • Known Human Immunodeficiency Virus seropositivity
  • Positive serology for hepatitis B defined by a positive test for HBsAg
  • Concurrent participation in another therapeutic treatment trial
  • High screening liver function tests
  • Prior treatment with CD74 targeting therapy
  • Patients requiring anti-coagulant therapy

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1804019161

ClinicalTrials.gov:

NCT03424603

Sponsor:

STRO-001-BCM1

Status

Open to Enrollment

Age Group

Adult

Sponsor