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

NCT03999658 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: STI-3031-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral T Cell Lymphoma; Diffuse Large B Cell Lymphoma; Biliary Tract Cancer; Extranodal NK T Cell Lymphoma, Nasal

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

Outcome Measures

Primary Outcomes (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

  Approximately 24 months

Secondary Outcomes (13)

• Objective Response Rate by treating physician

  Approximately 24 months

• Duration of Response

  Approximately 24 months

• Complete Response Rate

  Approximately 24 months

• Duration of Complete Response Rate

  Approximately 24 months

• Progressive-free survival

  Approximately 24 months

Study Arms (4)

Extranodal NK/T-cell lymphoma (ENKTL)

EXPERIMENTAL

Intravenous STI-3031 (anti-PD-L1 antibody)

Biological: STI-3031

Peripheral T-cell lymphomas (PTCL)

EXPERIMENTAL

Intravenous STI-3031 (anti-PD-L1 antibody)

Biological: STI-3031

Diffuse large B-cell lymphoma (DLBCL)

EXPERIMENTAL

Intravenous STI-3031 (anti-PD-L1 antibody)

Biological: STI-3031

Biliary tract cancers (BTC)

EXPERIMENTAL

Intravenous STI-3031 (anti-PD-L1 antibody)

Biological: STI-3031

Interventions

STI-3031 BIOLOGICAL

anti-PD-L1 antibody

Also known as: IMC-001

Biliary tract cancers (BTC); Diffuse large B-cell lymphoma (DLBCL); Extranodal NK/T-cell lymphoma (ENKTL); Peripheral T-cell lymphomas (PTCL)

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, Large B-Cell, Diffuse; Biliary Tract Neoplasms; Lymphoma, Extranodal NK-T-Cell; Cholangiocarcinoma; Gallbladder Neoplasms; Recurrence

Interventions

IMC-001

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Gallbladder Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: March 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share