Maintenance Immunotherapy for Unresectable Pancreatic Cancer
This study is testing two immunotherapy drugs, Odetiglucan and Mitazalimab, as a maintenance treatment for people with pancreatic adenocarcinoma (a type of pancreatic cancer) that cannot be removed by surgery. You might be able to join if you are 18 or older, have this type of cancer, and have already received 4 to 8 months of initial chemotherapy without your cancer getting worse. The researchers want to see if this combination of drugs can help keep the cancer from growing for at least 7.5 months. The study aims to enroll 100 participants, but the current status of enrollment is unclear.
- Study design
- This is a Phase II, open-label, single-arm study, meaning all participants receive the study drugs and everyone knows what treatment is being given. It plans to enroll 100 participants across different groups.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to measure how long participants live without their cancer progressing, with a target of 7.5 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07199764
Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of PennsylvaniaInvestigator-initiated
~100 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:OdetiglucanMitazalimab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Median progression-free survival (mPFS) of 7.5 months in Cohort A
Measured over 7.5 months
Conditions
NCT07199764
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvaniano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
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.
Have resolution of all chemotherapy-related toxicities to pre-treatment levels with exception of alopecia (which can be ongoing) and neuropathy (which can be ≤ Grade 2).
Eastern Cooperative Oncology (ECOG) performance status of 0 to 1.
Measurable disease per RECIST v1.1 (Section 17.2) is a requirement for study entry.
Willingness to undergo pre-treatment and on-treatment tumor biopsies. Tumor biopsies are mandatory for all patients with accessible disease, unless determined to be medically infeasible by the investigator.
Adequate organ function confirmed by the following laboratory values obtained ≤14 days prior to first administration of study treatment on Day 1:
Absolute neutrophil count (ANC) ≥1.5 x 109/L
Platelets ≥100 x 109/L
Hemoglobin ≥9 g/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN); if liver metastases, then ≤5 x ULN
Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN
Estimated glomerular filtration rate (GFR) (CLCr) ≥45 mL/min using Cockcroft Gault formula
Females of childbearing potential \[defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time during the preceding 24 consecutive months)\] must:
Have a negative serum or urine pregnancy test (β-human chorionic gonadotropin, β-hCG) as verified by the study investigator within 14 days prior to study treatment.
Commit to complete abstinence from heterosexual contact or agree to use medical doctor-approved contraception throughout the study without interruption while receiving study treatment and for at least 120 days following last dose of study treatment.
Males must practice complete abstinence or agree to use a condom (even if he has undergone a successful vasectomy) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 120 days following last dose of study treatment.
Exclusion
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)
An ongoing or active infection requiring intravenous antibiotics, antivirals, or antifungals during the 14 days prior to first dose of study drug
An uncontrolled concurrent illness, symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, or cardiac arrhythmia
History of (non-infectious) pneumonitis that required steroids, current pneumonitis, or a history of interstitial lung disease
QT interval corrected for heart rate using Fridericia's (QTcF) method \>450 msec for males and \>460 msec for females
A history of myocardial infarction within 6 months or a history of arterial thromboembolic event within 3 months of the first dose of investigational agent
A history of human immunodeficiency virus (HIV), hepatitis B (HB), or hepatitis C, except for the following:
Patients with anti-HB core antibody but with undetectable HB virus deoxyribonucleic acid (DNA) and negative for HB surface antigen
Patients with resolved or treated hepatitis C virus (HCV) (i.e. HCV antibody positive but undetectable HCV RNA)
Received concurrent or prior use of an immunosuppressive agent within 14 days of the first dose of investigational agent, with the following exceptions and notes:
Systemic steroids at physiologic doses (equivalent to dose of 10 mg oral prednisone) are permitted
Intranasal, inhaled, topical intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted
Patients must not have known, symptomatic brain or leptomeningeal metastases
Major surgical procedure within 21 days prior to first dose of study drug. Non-study related minor surgical procedures requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration. In all cases, patients must be sufficiently recovered and stable before treatment administration
Other malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancer; or any other cancer from which the patient has been disease-free for at least 3 years
Received a live vaccine within 28 days before the first dose of study drug. If enrolled, patients should not receive live vaccines during the study or for 28 days after the last dose of study treatment (Note: seasonal influenza vaccines for injection are generally inactivated and are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed)
Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate
Known alcohol or drug abuse
Any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent
What this trial measures
- Median progression-free survival (mPFS) of 7.5 months in Cohort A7.5 months
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.