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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
anti-PD-L1 antibody
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
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
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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
Time frame: Approximately 30 months (18 months for enrollment plus 12 months follow-up for the last participant enrolled)
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
Time frame: Approximately 24 months
Area Under the Curve (AUC) of the blood levels of STI-3031
Measure the actual body exposure to STI-3031
Time frame: Approximately 24 months
Maximum Plasma Concentration (Cmax) of STI-3031
Measure the maximum (or peak) blood concentration of STI-3031
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
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%
Time frame: Approximately 24 months
Immunogenicity
Incidence of anti-drug antibody (ADA) (serum titers of anti-STI-3031 antibodies) and correlation with exposure and activity
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months