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

Summary

Objectives

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).