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Peripheral T Cell LymphomaPhase 2NCT03999658

A Study of STI-3031 (an Anti-PD-L1 Antibody) in Patients With Selected Relapsed/Refractory Malignancies

A Phase 2 study testing STI-3031 in people with Peripheral T Cell Lymphoma and Diffuse Large B Cell Lymphoma, run by Sorrento Therapeutics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
STI-3031
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2023to Jul 2024
Phase
Phase 2
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

  • Documented histologically confirmed diagnoses of Extranodal NK/T-cell lymphoma, Peripheral T-cell lymphoma, Diffuse Large B-cell lymphoma (with a PD-L1 gene abnormality or Epstein-Barr virus positivity, or biliary tract cancer.
  • Prior treatment:
  • Extranodal NK/T-cell lymphoma: Must have received at least 1 previous line of systemic therapy including an asparaginase-based regimen.
  • Peripheral T-cell lymphoma: must have received at least 1 previous line of systemic multi-agent chemotherapy. Participants with anaplastic large cell lymphoma (ALCL) must have received brentuximab vedotin
  • Diffuse Large B-cell lymphoma: Must have received at least 2 previous lines of systemic therapy including an anti-CD20 antibody
  • Biliary Tract Cancer: Must have received at least 1 previous line of systemic therapy including gemcitabine with or without platinum
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  • Documented disease progression during or after the last therapy
  • If not previously treated with transplant, Investigator considers the participant ineligible for transplant
  • Measurable disease
  • Adult age (as defined by respective country) at time of signing informed consent form (ICF)
  • Must be able to understand the nature of the study and provide a signed and dated, written ICF prior to any study-specific procedures, sample collections and analyses
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
  • Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment and radiopharmaceuticals are permitted if more than 8 weeks have elapsed since the end of treatment
  • At least 14 days or 5 half-lives must have elapsed since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to < Grade 2
  • Adequate hematologic, renal and hepatic function
  • Females of childbearing potential (FCBP) must agree to use a reliable form of contraceptive during the study treatment period and for at least 90 days following the last dose of study intervention
  • Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 90 days after the last dose of study intervention
  • Predicted life expectancy of at least 16 weeks

Who cannot join

  • Current participation in another therapeutic clinical trial
  • Prior treatment with an anti-PD-L1 or anti-PD-1 antibody
  • Patients with symptomatic central nervous system (CNS) metastases unless considered adequately treated and controlled for at least 2 weeks
  • Prior hematopoietic stem cell transplantation
  • History of other previous cancer that would interfere with the determination of safety or efficacy
  • Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo, hormone replacement therapy for stable thyroid diseases and Type 1 diabetes mellitus
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  • Apparent active or latent tuberculosis (TB) infection
  • Seropositive for or have active infection with hepatitis C virus (HCV), unless HCV viral load is below the limit of quantification and participant is on concurrent viral suppressive therapy
  • Seropositive for or have active viral infection with hepatitis B virus (HBV), unless HBV viral load is below the limit of quantification and participant is on concurrent viral suppressive therapy
  • Seropositive for or active viral infection with HIV, unless the following are met:
  • CD4+ T-cell (CD4+) counts ≥ 350 cells/uL; and
  • Participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to screening and have HIV viral load < 400 copies/mL; and
  • Participant has not had acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months prior to screening
  • Active infection (viral, bacterial, or fungal) requiring intravenous (IV) systemic therapy within 14 days
  • Evidence of bleeding diathesis or coagulopathy.
  • Significant proteinuria
  • Conditions requiring chronic steroid use (> 10 mg/day of prednisone or equivalent).
  • Recent history of attenuated viral vaccination within 30 days prior to the first dose of study intervention
  • Herbal preparations/medications are not allowed throughout the treatment period unless first discussed with and approved by the Medical Monitor
  • History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients.
  • Known current drug or alcohol abuse
  • Major surgical procedures ≤ 28 days prior to the first dose of study intervention, or minor surgical procedures ≤7 days prior to the first dose of study intervention
  • Pregnant or lactating
  • Any of the following cardiac diseases currently or within the last 6 months:
  • QT interval corrected using Fridericia's formula >450 milliseconds in men and > 470 milliseconds in women (up to 480 milliseconds may be allowed after discussion between the Investigator and the Medical Monitor).
  • Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
  • Unstable angina pectoris
  • Congestive heart failure (New York Heart Association ≥ Grade 2)
  • Acute myocardial infarction
  • Clinically significant conduction abnormality not controlled with pacemaker or medication
  • Significant ventricular or supraventricular arrhythmias (Participants with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible.)
  • Underlying medical conditions that, in the opinion of the investigator and/or medical monitor, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results

About this study

Official title: An Open-label, Multicenter, Global Phase 2 Basket Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of STI-3031 in Patients With Selected Relapsed or Refractory Malignancies.

This study evaluates the efficacy, as measured by the objective response rate, of STI-3031, an anti-PD-L1 antibody, in previously treated patients with selected advanced lymphomas or biliary tract cancer.

Read the detailed description

This is an open-label, multicenter, global Phase 2 basket study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of STI-3031 in patients with selected relapsed or refractory (R/R) malignancies. The study will be conducted as separate Phase 2, single arm substudies for each of the indications below:

  • Extranodal NK/T-cell lymphoma (ENKTL)
  • Peripheral T-cell lymphomas (PTCL)
  • Diffuse large B-cell lymphoma (DLBCL) with PD-L1 gene translocation, copy gain, amplification, polysomy detectable by a fluorescence in situ hybridization (FISH) assay or Epstein-Barr virus positivity (EBV+) as assessed by EBV-encoded small RNA (EBER) testing
  • Biliary tract cancers (BTC) (intrahepatic cholangiocarcinoma), extrahepatic cholangiocarcinoma or gallbladder cancer)

All participants will receive the study intervention, STI-3031.

Being tested
STI-3031
Keywords
ENKTL, DLBCL, PTCL, cholangiocarcinoma, gall bladder cancer, relapsed, refractory, T/NK-cell, NK/T-cell, peripheral T-cell, PD-L1, anti-PD-L1 antibody
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse, Biliary Tract Neoplasms, Lymphoma, Extranodal NK-T-Cell, Cholangiocarcinoma, Gallbladder Neoplasms, Recurrence

What participants receive

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

  • STI-3031Biological

    Also called IMC-001

    anti-PD-L1 antibody

Study groups in NCT03999658
Study groupRoleWhat they receive
Extranodal NK/T-cell lymphoma (ENKTL)ExperimentalIntravenous STI-3031 (anti-PD-L1 antibody)
Receives: Biological: STI-3031
Peripheral T-cell lymphomas (PTCL)ExperimentalIntravenous STI-3031 (anti-PD-L1 antibody)
Receives: Biological: STI-3031
Diffuse large B-cell lymphoma (DLBCL)ExperimentalIntravenous STI-3031 (anti-PD-L1 antibody)
Receives: Biological: STI-3031
Biliary tract cancers (BTC)ExperimentalIntravenous STI-3031 (anti-PD-L1 antibody)
Receives: Biological: STI-3031

What is being measured

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

  1. Objective Response Rate

    Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) at any time during the study as assessed by an Independent Response Committee (IRC) per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

Secondary outcomes (13)

  1. Objective Response Rate by treating physician

    Percentage of participants achieving a CR or PR at any time during the study as assessed by the Investigator per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

  2. Duration of Response

    Time from the first documentation of response (CR or PR) to the first documentation of progressive disease (PD) as assessed by an IRC per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

  3. Complete Response Rate

    Percentage of participants achieving a CR at any time during the study as assessed by an IRC per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

  4. Duration of Complete Response Rate

    Time from the first documentation of CR to the first documentation of PD as assessed by an IRC per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

  5. Progressive-free survival

    Time from enrollment until PD or death as assessed by an IRC per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

  6. 12-month Progressive-free survival

    Percentage of participants without PD or death at 12 months after their first dose of study intervention as assessed by an IRC per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 30 months (18 months for enrollment plus 12 months follow-up for the last participant enrolled)

  7. Event free survival

    Time from enrollment to PD, death, or start of new treatment as assessed by an IRC per the Lugano criteria with LYRIC modification or RECIST 1.1

    Measured: Approximately 24 months

  8. Area Under the Curve (AUC) of the blood levels of STI-3031

    Measure the actual body exposure to STI-3031

    Measured: Approximately 24 months

  9. Maximum Plasma Concentration (Cmax) of STI-3031

    Measure the maximum (or peak) blood concentration of STI-3031

    Measured: Approximately 24 months

  10. Time of Maximum concentration observed (Tmax) of STI-3031

    Measure the is the time at which the maximum blood concentration of STI-3031 is observed

    Measured: Approximately 24 months

  11. Half-life (t1/2) of STI-3031

    Measure the time it takes for the concentration of the drug in the blood to be reduced by 50%

    Measured: Approximately 24 months

  12. Immunogenicity

    Incidence of anti-drug antibody (ADA) (serum titers of anti-STI-3031 antibodies) and correlation with exposure and activity

    Measured: Approximately 24 months

  13. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of STI-3031

    Terms, frequency, severity and seriousness of adverse events (AEs) and relationship of AEs to STI-3031 the actual body exposure to drug after administration

    Measured: Approximately 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 posted27 Jun 2019
  2. Study startMar 2023 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Why it stopped: Sorrento Therapeutics filed for chapter 11 bankruptcy.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03999658
Sponsor's protocol ID
STI-3031-001
Status last verified
Apr 2023
First submitted
24 Jun 2019
Last updated
1 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STI-3031 in people with Peripheral T Cell Lymphoma and Diffuse Large B Cell Lymphoma, run by Sorrento Therapeutics, Inc..

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 18 inclusion and 32 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: withdrawn, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Objective Response Rate (time frame: Approximately 24 months). 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 NCT03999658.

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 1 May 2023.

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