Non Hodgkin Lymphoma Clinical Trial

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

Summary

First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 3 weeks.

View Full Description

Full 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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Confirmation of diagnosis
Relapsed or relapsed/refractory disease
Age ≥ 18 years
ECOG performance status (0-2)
Life expectancy > 3 months
Adequate bone marrow and renal functions
QTcF <500 msec
Ability to comply with treatment, PK and test schedules
NHL only- at least one measurable lesion

Key Exclusion Criteria:

Active plasma cell leukemia and/or leukemic manifestations of lymphoma
Known amyloidosis (MM patients)
Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects)
T-cell malignancy
Sensory or motor neuropathy ≥ grade 2
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
Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Subjects may be using topical or inhaled corticosteroids.
Clinically significant cardiac disease
Significant concurrent, uncontrolled medical condition
History or clinical signs of meningeal or active CNS involvement
Known severe chronic obstructive pulmonary disease or asthma
History of significant cerebrovascular disease
Known Human Immunodeficiency Virus seropositivity
Positive serology for hepatitis B defined by a positive test for HBsAg
Concurrent participation in another therapeutic treatment trial
High screening liver function tests
Prior treatment with CD74 targeting therapy

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT03424603

Recruitment Status:

Recruiting

Sponsor:

Sutro Biopharma, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 23 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Avery Hillary
Contact
[email protected]
Gaurav Goyal, MD
Principal Investigator
Arizona Oncology Associates, PC--HOPE Division
Tucson Arizona, 85711, United States
City of Hope Medical Center
Duarte California, 91010, United States More Info
Amrita Krishnan, M.D.
Contact
626-256-4673
[email protected]
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Elizbeth Guy
Contact
916-734-3604
[email protected]
Joseph Tuscano, MD
Principal Investigator
Univeristy of California San Francisco HDF Comprehensive Cancer Center
San Francisco California, 94143, United States
Rocky Mountain Cancer Center
Aurora Colorado, 80012, United States
Emory University Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Jonathan Kaufman, MD
Principal Investigator
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
University of Kansas Cancer Center
Fairway Kansas, 66205, United States
University of Maryland Medical Center
Baltimore Maryland, 21201, United States More Info
Meghan Luhowey
Contact
410-328-2243
Ashraf Badros, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Connor Regan
Contact
617-726-8566
[email protected]
Jeremy Abramson, MD
Principal Investigator
Henry Ford Cancer Institute
Detroit Michigan, 48202, United States More Info
Karen Leszczynski, RN, CCRC
Contact
313-916-3590
[email protected]
Ahmad H Mattour, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Dana Ostrowski, RN
Contact
212-824-7375
[email protected]
Jonah Shulman, MD
Principal Investigator
Weill Cornell Medicine
New York New York, 10065, United States More Info
Kathleen Pogonowski
Contact
646-962-6500
[email protected]
Ruben Niesvizky, M.D.
Principal Investigator
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Texas Oncology
Austin Texas, 78705, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States More Info
Silviya Meletath
Contact
214-648-4180
[email protected]
Farrukh Awan, MD
Principal Investigator
Texas Oncology - Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
UT Health San Antonio
San Antonio Texas, 78229, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Karin Choquette, MSN/RN
Contact
571-389-0873
[email protected]
Alexander Spira, MD, PhD
Principal Investigator
West Virginia University
Morgantown West Virginia, 26505, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

220

Study ID:

NCT03424603

Recruitment Status:

Recruiting

Sponsor:


Sutro Biopharma, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.