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

NCT03424603 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: STRO-001-BCM1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

B-cell Lymphoma; Non Hodgkin Lymphoma; Multiple Myeloma; Follicular Lymphoma; Mantle Cell Lymphoma; Diffuse Large B Cell Lymphoma; Indolent Lymphoma; B Cells--Tumors

Outcome Measures

Primary Outcomes (4)

• Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-001)

  Incidence of adverse events (AEs) observed across STRO-001 dose levels

  18 months

• Part 1: Define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of STRO-001

  Frequency of dose-limiting toxicity and exposure across STRO-001 dose levels

  18 months

• Part 2: Evaluate preliminary anti-tumor activity (multiple myeloma patients)

  Objective response rates per International Myeloma Working Group (IMWG) criteria for response assessment

  24 months

• Part 2: Evaluate preliminary anti-tumor activity (NHL patients)

  Objective response rates per the Lugano classification for response assessment

  24 months

Secondary Outcomes (13)

• Part 1: Characterize the pharmacokinetics (PK) of STRO-001 by measuring the maximum plasma concentration (Cmax)

  18 months

• Part 1: Characterize the PK of STRO-001 by measuring the half-life (t1/2) of STRO-001

  18 months

• Part 1: Characterize the PK of STRO-001 measuring the total area under the concentration versus time curve from zero to infinity (AUCinf)

  18 months

• Part 1: Characterize the PK of STRO-001 by measuring the clearance (CL)

  18 months

• Part 1: Characterize the PK of STRO-001 by measuring the the steady state volume of distribution (Vss)

  18 months

Other Outcomes (2)

• Part 1: Preliminary assessment of the anti-tumor activity of STRO-001 (multiple myeloma patients)

  18 months

• Part 1: Preliminary assessment of the anti-tumor activity of STRO-001 (NHL)

  18 months

Study Arms (1)

STRO-001

EXPERIMENTAL

intravenous

Drug: STRO-001

Interventions

STRO-001 DRUG

intravenous antibody drug conjugate

STRO-001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutro Biopharma, Inc.: lead

Study Sites (22)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Associates, PC--HOPE Division

Tucson, Arizona, 85711, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Univeristy of California San Francisco HDF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Rocky Mountain Cancer Center

Aurora, Colorado, 80012, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

Texas Oncology

Austin, Texas, 78705, United States

Location

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• ASH conference, Dec 2017 oral presentation NHL abstract
• ASH conference, Dec 2017 poster presentation multiple myeloma abstract

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Multiple Myeloma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Officials

• Arturo Molina, MD

  Sutro Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 7, 2018
• Study Start: February 22, 2018
• Primary Completion: February 15, 2024
• Study Completion: March 15, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

US (22)