Actively Recruiting
Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer
Led by University of Pennsylvania · Updated on 2026-03-06
100
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
L
Lustgarten Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 4-6 months of first line (1L) chemotherapy.
CONDITIONS
Official Title
Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years old
- Able to understand study procedures and provide written informed consent
- Histologically or cytologically confirmed pancreatic adenocarcinoma that is locally advanced and unresectable or metastatic
- Received 16 to 24 weeks of first-line chemotherapy resulting in partial response or stable disease without progression within 14 days before study treatment
- Resolution of chemotherapy-related toxicities to pre-treatment levels except ongoing alopecia and neuropathy 64 Grade 2
- ECOG performance status of 0 to 1
- Measurable disease per RECIST v1.1
- Willingness to undergo mandatory tumor biopsies if disease is accessible
- Adequate organ function based on laboratory tests within 14 days before treatment
- For females of childbearing potential, negative pregnancy test and agreement to use contraception or abstain from heterosexual contact during and for 120 days after treatment
- For males, agreement to abstain or use condoms during study and for 120 days after last dose
You will not qualify if you...
- Prior treatment with CD40 antibodies or other immunomodulatory agents for cancer
- Prior exposure to odetiglucan
- Systemic treatment for pancreatic adenocarcinoma within 14 days before study drug
- Active or inactive autoimmune diseases requiring systemic treatment in past 2 years or current systemic therapy, except certain stable conditions
- Active infection requiring IV antibiotics, antivirals, or antifungals within 14 days before study drug
- Uncontrolled illnesses including severe heart failure, unstable angina, uncontrolled hypertension, or arrhythmia
- History of pneumonitis requiring steroids, current pneumonitis, or interstitial lung disease
- Prolonged QT interval (>450 msec males, >460 msec females)
- Recent myocardial infarction (within 6 months) or arterial thromboembolic event (within 3 months)
- HIV, hepatitis B or C infection except controlled or resolved cases
- Use of immunosuppressive agents within 14 days before study drug except low-dose steroids and certain corticosteroids
- Known symptomatic brain or leptomeningeal metastases
- Major surgery within 21 days before study drug; minor surgery must be recovered and stable
- Other malignancies unless disease-free for at least 3 years or certain skin cancers
- Live vaccines within 28 days before study drug or during study
- Pregnant or lactating females or planning pregnancy during study
- Known alcohol or drug abuse
- Any significant psychiatric, social, or medical condition that may increase risk or interfere with study adherence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Abramson Cancer Center Clinical Trials Service
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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