First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy
of STRO-001 given intravenously every 3 weeks.
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 evaluate the safety, tolerability, and preliminary anti-tumor activity of
STRO-001 in adult subjects with B-cell malignancies (MM and NHL) who are refractory to, or
intolerant of, all established therapy known to provide clinical benefit for their condition
(i.e., trial subjects must not be candidates for any regimens known to provide clinical
benefit). The study will consist of two parts: Part 1, dose escalation, and Part 2, dose
The study uses an accelerated dose titration design for dose escalation. Doses will be
escalated using an N-of-1 per dosing cohort until the first instance of a treatment-related,
clinically relevant Grade 2 non-hematologic toxicity or a Grade 3 hematologic toxicity of any
type is observed during Cycle 1 (first 21 days). Following this a standard 3+3 trial design
is used for all further escalation cohorts. Dose escalation is conducted independently for
the two dose escalation tumor cohorts (MM and NHL). A recommended STRO-001 dose for expansion
will be determined for MM and NHL.
The dose expansion (Part 2) portion of the study will begin when Part 1 is completed.
Enrollment in dose expansion will include separate tumor cohorts of MM and NHL.
In both Part 1 and Part 2 of the study, STRO-001 will be dosed as an intravenous (IV)
infusion on Day 1 of a 21-day cycle, until disease progression. Labs will be drawn on a
weekly basis for Cycles 1-4, and every three weeks starting with Cycle 5. Weekly clinical
evaluations will be conducted during the first 4 cycles; thereafter, clinical evaluations
will be conducted on infusion days (Day 1 of each cycle). Samples for pharmacokinetics (PK)
analysis will occur at specific times on Days 1, 2, and 8 of the first two cycles of
treatment, Day 1 of the third cycle of treatment and at End of Treatment visit. Additional
clinical evaluations and labs may occur at the discretion of the investigator.
Subjects who receive any dose of STRO-001 will be included in safety analyses. Disease
evaluations will include peripheral blood analysis, bone marrow assessments and scans as
appropriate. Disease status will be evaluated per MM-specific or NHL-specific criteria.
Samples will be collected to assess the PK and immunogenicity of STRO-001. Biomarkers may be
assessed from bone marrow, peripheral blood and/or tissue samples. Subjects will continue to
receive study drug until disease progression, unacceptable toxicity, withdrawal of consent,
or end of study (study completion).
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
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