NCT03999658

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

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.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	STI-3031	anti-PD-L1 antibody

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-01-01
• Completion: 2024-07-01
• First posted: 2019-06-27
• Last updated: 2023-05-01

Regulatory

• FDA-regulated drug study