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Brief Title: Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Official Title: A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Study ID: NCT03424603
Brief Summary: First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks.
Detailed Description: 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Associates, PC--HOPE Division, Tucson, Arizona, United States
City of Hope Medical Center, Duarte, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Univeristy of California San Francisco HDF Comprehensive Cancer Center, San Francisco, California, United States
Rocky Mountain Cancer Center, Aurora, Colorado, United States
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Kansas Cancer Center, Fairway, Kansas, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Henry Ford Cancer Institute, Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Weill Cornell Medicine, New York, New York, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Texas Oncology, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
UT Health San Antonio, San Antonio, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Name: Arturo Molina, MD
Affiliation: Sutro Biopharma
Role: STUDY_DIRECTOR