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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

  1. Confirmation of diagnosis
  2. Relapsed or relapsed/refractory disease
  3. Age ≥ 18 years
  4. ECOG performance status (0-2)
  5. Life expectancy > 3 months
  6. Adequate bone marrow and renal functions
  7. QTcF <500 msec
  8. Ability to comply with treatment, PK and test schedules
  9. NHL only- at least one measurable lesion

Key Ex

Exclusion Criteria

  1. Active plasma cell leukemia and/or leukemic manifestations of lymphoma
  2. Known amyloidosis (MM patients)
  3. Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects)
  4. T-cell malignancy
  5. Sensory or motor neuropathy ≥ grade 2
  6. 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
  7. Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Subjects may be using topical or inhaled corticosteroids.
  8. Clinically significant cardiac disease
  9. Significant concurrent, uncontrolled medical condition
  10. History or clinical signs of meningeal or active CNS involvement
  11. Known severe chronic obstructive pulmonary disease or asthma
  12. History of significant cerebrovascular disease
  13. Known Human Immunodeficiency Virus seropositivity
  14. Positive serology for hepatitis B defined by a positive test for HBsAg
  15. Concurrent participation in another therapeutic treatment trial
  16. High screening liver function tests
  17. 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