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

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 expansion.

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).