Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-8 months of first line (1L) chemotherapy.
Age ≥ 18 years old
Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma that is either locally advanced and unresectable, or metastatic
Have received a minimum of 16 and no more than 32 weeks of a first line chemotherapy-based standard of care regimen, resulting in either a PR or SD with no evidence of progression within 14 days prior to first dose of study treatment.
Prior exposure to CD40 antibodies or any other immunomodulatory agent for the treatment of cancer
Prior exposure to odetiglucan
Received any systemic treatment for pancreatic adenocarcinoma within 14 days prior to the first dose of study therapy. For investigational agents, patients must not have had treatment within a time interval less than at least 5 half-lives of the investigational agent prior to the first scheduled day of dosing in this study
Had any active or inactive autoimmune disease or syndrome that required systemic treatment in the past 2 years, or currently requires systemic therapy with disease-modifying agents, corticosteroids, or immunosuppressive drugs. Examples include but are not limit to: rheumatoid arthritis, systemic sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Granulomatosis with polyangiitis, formerly Wegener's Granulomatosis), multiple sclerosis, inflammatory bowel disease, or motor neuropathies of autoimmune origin (e.g. Guillain-Barre Syndrome)
Parallel
Odetiglucan
DrugOdetiglucan 4 mg/kg IV every 3 weeks
Mitazalimab
DrugMitazalimab 0.9 mg/kg IV every 3 weeks
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Treatment groupsSee each treatment group below.
Median progression-free survival (mPFS) of 7.5 months in Cohort A
The primary endpoint of the trial is median progression-free survival (mPFS) of 7.5 months in Cohort A, defined as the time from treatment initiation to disease progression or death from any cause. PFS will be assessed using imaging per RECIST v1.1 criteria, with analysis conducted using Kaplan-Meier methodology and a log-rank test.
Safety and tolerability of maintenance odetiglucan/mitazalimab
To evaluate safety and tolerability of maintenance odetiglucan/mitazalimab. Safety assessed by CTCAE v5.0 criteria.
Progression-free survival (PFS) in Cohort B
To estimate progression-free survival (PFS) of maintenance odetiglucan/mitazalimab in patients (Cohort B) with metastatic pancreatic adenocarcinoma who achieve stable disease after 4-6 months of 1L chemotherapy.
Progression-free survival (PFS) in Cohort C
To estimate progression-free survival (PFS) of maintenance odetiglucan/mitzalimab in patients (Cohort C) with pancreatic adenocarcinoma but without metastatic disease who achieve either a PR or SD after 4-6 months of 1L chemotherapy
Overall response rate (ORR) (Cohorts A-C)
To estimate efficacy parameters of maintenance odetiglucan/mitazalimab in all patients (Cohorts A-C) by assessing overall response rate (ORR) using RECIST v1.1 and iRECIST
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University of Pennsylvania
Lead sponsor
Lustgarten Foundation
Collaborator
