Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies

ID#: NCT03424603

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: February 22, 2018

End Date: November 01, 2023

Contact Information:
Jason Kuriakose
Summary: First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks.
Eligibility: Key

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

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