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

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ClinicalTrials.gov Identifier: NCT03424603
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sutro Biopharma, Inc.

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE February 7, 2018
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE February 22, 2018
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-001) [ Time Frame: 18 months ]
    Incidence of adverse events (AEs) observed across STRO-001 dose levels
  • Part 1: Define the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of STRO-001 [ Time Frame: 18 months ]
    Frequency of dose-limiting toxicity and exposure across STRO-001 dose levels
  • Part 2: Evaluate preliminary anti-tumor activity (multiple myeloma patients) [ Time Frame: 24 months ]
    Objective response rates per International Myeloma Working Group (IMWG) criteria for response assessment
  • Part 2: Evaluate preliminary anti-tumor activity (NHL patients) [ Time Frame: 24 months ]
    Objective response rates per the Lugano classification for response assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03424603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Part 1: Characterize the pharmacokinetics (PK) of STRO-001 by measuring the maximum plasma concentration (Cmax) [ Time Frame: 18 months ]
    Measurement of maximum plasma concentration after the administration of STRO-001
  • Part 1: Characterize the PK of STRO-001 by measuring the half-life (t1/2) of STRO-001 [ Time Frame: 18 months ]
    Measurement of terminal half-life of STRO-001 after the administration of STRO-001
  • Part 1: Characterize the PK of STRO-001 measuring the total area under the concentration versus time curve from zero to infinity (AUCinf) [ Time Frame: 18 months ]
    Measurement of AUC to infinity (AUCinf)
  • Part 1: Characterize the PK of STRO-001 by measuring the clearance (CL) [ Time Frame: 18 months ]
    Measurement of total body clearance
  • Part 1: Characterize the PK of STRO-001 by measuring the the steady state volume of distribution (Vss) [ Time Frame: 18 months ]
    Measurement of steady state volume of distribution
  • Part 1: Assess the immunogenic potential of STRO-001 [ Time Frame: 18 months ]
    Evaluation and quantitation of circulating anti-drug antibodies (ADAs) over time
  • Part 2: Further evaluate the incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-001) [ Time Frame: 24 months ]
    Number of patients with abnormal laboratory values and/or adverse events related to STRO-001 treatment
  • Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of duration of response (DOR) in patients treated with STRO-001 [ Time Frame: 24 months ]
    Each cohort will be analyzed independently
  • Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of progression-free survival (PFS) in patients treated with STRO-001 [ Time Frame: 24 months ]
    Each cohort will be analyzed independently
  • Part 2: Characterize the PK of STRO-001 by measuring the maximum plasma concentration (Cmax) [ Time Frame: 24 months ]
    Measurement of maximum plasma concentration after the administration of STRO-001
  • Part 2: Characterize the PK of STRO-001 by measuring the half-life (t1/2) of STRO-001 [ Time Frame: 24 months ]
    Measurement of terminal half-life of STRO-001 after the administration of STRO-001
  • Part 2: Characterize the PK of STRO-001 by measuring the area under the plasma concentration versus time curve (AUC) [ Time Frame: 24 months ]
    Measurement of AUC to infinity (AUC inf)
  • Part 2: Characterize the PK of STRO-001 by measuring the clearance (CL) [ Time Frame: 24 months ]
    Measurement of total body clearance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 31, 2018)
  • Part 1: Preliminary assessment of the anti-tumor activity of STRO-001 (multiple myeloma patients) [ Time Frame: 18 months ]
    Objective response rates per IMWG criteria for response assessment
  • Part 1: Preliminary assessment of the anti-tumor activity of STRO-001 (NHL) [ Time Frame: 18 months ]
    Objective response rates per the Lugano classification for response assessment (NHL patients)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies
Official Title  ICMJE 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
Brief Summary First-in-human Phase 1 trial to study the safety, pharmacokinetics and preliminary efficacy of STRO-001 given intravenously every 2 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.

During Part 1 (dose escalation), an accelerated dose titration design will be applied to cohorts A (MM) and B (NHL). Doses will be escalated using an N-of-1 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 28 days). Any event meeting these criteria will be reviewed and confirmed by the Safety Evaluation Team (SET). Each dose escalation cohort will be assessed independently. When these criteria are met then the dose is expanded with 2 additional subjects and the standard 3+3 trial design is used for all further dosing cohorts. The dose escalation (Part 1) phase of the study will be complete when the MTD is determined and the recommended dose for Part 2 (dose expansion) is identified. The RP2D will be selected based on the safety, tolerability and exposure of STRO-001, and will be the end of Part 1 of the study. After determination of the RP2D, subjects with MM or NHL will be enrolled into indication specific dose expansion cohorts (Part 2). The accelerated dose titration (N-of-1) design with seamless transformation into a traditional 3+3 design allows for very low starting doses to be evaluated in fewer patients.

In both Part 1 and Part 2 of the study, STRO-001 will be dosed as an intravenous (IV) infusion on Day 1 and Day 15 in 28-day cycles, until disease progression. Labs will be drawn on a weekly basis for Cycles 1-3, and every two weeks starting with Cycle 4. Weekly clinical evaluations will be conducted during Cycle 1; thereafter, clinical evaluations will be conducted on infusion days (Day 1 and Day 15 of each cycle). Samples for pharmacokinetics (PK) analysis will occur at specific times on Days 1, 2, 3, 8, 15, 16, 22, and 29 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-cell Lymphoma
  • Non Hodgkin Lymphoma
  • Multiple Myeloma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Indolent Lymphoma
  • B Cells--Tumors
Intervention  ICMJE Drug: STRO-001
intravenous antibody drug conjugate
Study Arms  ICMJE Experimental: STRO-001
intravenous
Intervention: Drug: STRO-001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  1. Active plasma cell leukemia and/or leukemic manifestations of lymphoma
  2. Known amyloidosis (MM patients)
  3. Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects)
  4. T-cell malignancy
  5. Sensory or motor neuropathy ≥ grade 2
  6. 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
  7. Ongoing immunosuppressive therapy, including systemic corticosteroids. Note: Subjects may be using topical or inhaled corticosteroids.
  8. Clinically significant cardiac disease
  9. Significant concurrent, uncontrolled medical condition
  10. History or clinical signs of meningeal or active CNS involvement
  11. Known severe chronic obstructive pulmonary disease or asthma
  12. History of significant cerebrovascular disease
  13. Known Human Immunodeficiency Virus seropositivity
  14. Positive serology for hepatitis B defined by a positive test for HBsAg
  15. Concurrent participation in another therapeutic treatment trial
  16. High screening liver function tests
  17. Prior treatment with CD74 targeting therapy
  18. Patients requiring anti-coagulant therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shannon Matheny, PhD 1-650-676-4610 STRO-001ClinDev@sutrobio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03424603
Other Study ID Numbers  ICMJE STRO-001-BCM1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sutro Biopharma, Inc.
Study Sponsor  ICMJE Sutro Biopharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Arturo Molina, MD Sutro Biopharma
PRS Account Sutro Biopharma, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP