Status:
COMPLETED
Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Lead Sponsor:
Sutro Biopharma, Inc.
Conditions:
B-cell Lymphoma
Non Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks.
Detailed Description
This study is a first-in-human Phase 1, open-label, multicenter, dose escalation study with dose expansion to identify the maximum tolerated dose (MTD), the recommended phase 2 doses (RP2D) and to eva...
Eligibility Criteria
Inclusion
- Key
- Confirmation of diagnosis
- Relapsed or relapsed/refractory disease
- Age ≥ 18 years
- ECOG performance status (0-2)
- Life expectancy \> 3 months
- Adequate bone marrow and renal functions
- QTcF \<500 msec
- Ability to comply with treatment, PK and test schedules
- NHL only- at least one measurable lesion
- Key
Exclusion
- Active plasma cell leukemia and/or leukemic manifestations of lymphoma
- Known amyloidosis (MM patients)
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03424603
Start Date
February 22 2018
End Date
March 15 2024
Last Update
June 11 2024
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Oncology Associates, PC--HOPE Division
Tucson, Arizona, United States, 85711
3
City of Hope Medical Center
Duarte, California, United States, 91010
4
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817