Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Lay Description
First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks.
Category
- Cancers and Other Neoplasms
- Multiple Myeloma
- Non-Hodgkin's Lymphoma
- IRB Number
- 20200030HU
- NCT Number
- NCT03424603
- Open to Enrollment
- Not set
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Ex
Exclusion Criteria
- 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
Study Design
Arm Groups
Study Contact
Regulatory Point of Contact
Matthew Butler
(210) 203-8047
ButlerMJ@uthscsa.edu
Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu
Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Principal Investigator
Matthew Butler