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B-cell LymphomaPhase 1NCT03424603

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

A Phase 1 study testing STRO-001 in people with B-cell Lymphoma and Non Hodgkin Lymphoma, run by Sutro Biopharma, Inc. at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
STRO-001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
22 sitesUnited States
Study dates
22 Feb 2018to 15 Mar 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • QTcF <500 msec
  • Ability to comply with treatment, PK and test schedules
  • NHL only- at least one measurable lesion

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Center

    Aurora, Colorado, 80012

  • Texas Oncology

    Austin, Texas, 78705

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202

  • City of Hope Medical Center

    Duarte, California, 91010

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia University

    Morgantown, West Virginia, 26505

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Weill Cornell Medicine

    New York, New York, 10065

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Univeristy of California San Francisco HDF Comprehensive Cancer Center

    San Francisco, California, 94143

  • Arizona Oncology Associates, PC--HOPE Division

    Tucson, Arizona, 85711

Other trials in United States

About this study

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

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

Read the 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).

Being tested
STRO-001
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STRO-001Drug

    intravenous antibody drug conjugate

Study groups in NCT03424603
Study groupRoleWhat they receive
STRO-001Experimentalintravenous
Receives: Drug: STRO-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 18 months

  2. 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

    Measured: 18 months

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

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

    Measured: 24 months

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

    Objective response rates per the Lugano classification for response assessment

    Measured: 24 months

Secondary outcomes (13)

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

    Measurement of maximum plasma concentration after the administration of STRO-001

    Measured: 18 months

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

    Measurement of terminal half-life of STRO-001 after the administration of STRO-001

    Measured: 18 months

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

    Measurement of AUC to infinity (AUCinf)

    Measured: 18 months

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

    Measurement of total body clearance

    Measured: 18 months

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

    Measurement of steady state volume of distribution

    Measured: 18 months

  6. Part 1: Assess the immunogenic potential of STRO-001

    Evaluation and quantitation of circulating anti-drug antibodies (ADAs) over time

    Measured: 18 months

  7. Part 2: Further evaluate the incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-001)

    Number of patients with abnormal laboratory values and/or adverse events related to STRO-001 treatment

    Measured: 24 months

  8. Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of duration of response (DOR) in patients treated with STRO-001

    Each cohort will be analyzed independently

    Measured: 24 months

  9. Part 2: Evaluate preliminary anti-tumor efficacy with a time-to-event analysis of progression-free survival (PFS) in patients treated with STRO-001

    Each cohort will be analyzed independently

    Measured: 24 months

  10. Part 2: Characterize the PK of STRO-001 by measuring the maximum plasma concentration (Cmax)

    Measurement of maximum plasma concentration after the administration of STRO-001

    Measured: 24 months

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

    Measurement of terminal half-life of STRO-001 after the administration of STRO-001

    Measured: 24 months

  12. Part 2: Characterize the PK of STRO-001 by measuring the area under the plasma concentration versus time curve (AUC)

    Measurement of AUC to infinity (AUC inf)

    Measured: 24 months

  13. Part 2: Characterize the PK of STRO-001 by measuring the clearance (CL)

    Measurement of total body clearance

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start22 Feb 2018
  3. Primary completion15 Feb 2024
  4. Study completion15 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424603
Sponsor's protocol ID
STRO-001-BCM1
Status last verified
Jun 2024
First submitted
24 Jan 2018
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing STRO-001 in people with B-cell Lymphoma and Non Hodgkin Lymphoma, run by Sutro Biopharma, Inc. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability of STRO-001) (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03424603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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