Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer

NCT07199764 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 859213
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  7.5 months

Secondary Outcomes (13)

• Safety and tolerability of maintenance odetiglucan/mitazalimab

  19.5 months

• Progression-free survival (PFS) in Cohort B

  7.5 months

• Progression-free survival (PFS) in Cohort C

  7.5 months

• Overall response rate (ORR) (Cohorts A-C)

  19.5 months

• Disease control rate (DCR) (Cohorts A-C)

  19.5 months

Study Arms (9)

Cohort A

EXPERIMENTAL

Patients with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy

Drug: Odetiglucan; Drug: Mitazalimab

Cohort B

EXPERIMENTAL

Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy

Drug: Odetiglucan; Drug: Mitazalimab

Cohort C

EXPERIMENTAL

Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy

Drug: Odetiglucan; Drug: Mitazalimab

Prospective Cohort A

NO INTERVENTION

Observational Prospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy

Prospective Cohort B

NO INTERVENTION

Observational Prospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy

Prospective Cohort C

NO INTERVENTION

Observational Prospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy

Retrospective Cohort A

NO INTERVENTION

Observational Retrospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy

Retrospective Cohort B

NO INTERVENTION

Observational Retrospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy

Retrospective Cohort C

NO INTERVENTION

Observational Retrospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy

Interventions

Odetiglucan DRUG

Odetiglucan 4 mg/kg IV every 3 weeks

Cohort A; Cohort B; Cohort C

Mitazalimab DRUG

Mitazalimab 0.9 mg/kg IV every 3 weeks

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 24 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.
• o Note: Patients must demonstrate at least stable disease (SD) or partial response (PR) by imaging. A single assessment showing PR at the end of chemotherapy (up to 24 weeks) is sufficient; confirmation is not required. If chemotherapy was discontinued between 16-24 weeks due to legitimate medical reasons (as determined by the investigator), the patient may still be eligible if they demonstrated SD or PR prior to discontinuation.
• 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

You may not qualify if:

• 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)
• o Note: Patients are permitted to enroll if they have vitiligo or resolved childhood asthma/atopy, hypothyroidism stable on hormone replacement, controlled asthma, psoriasis not requiring systemic treatment, Type I diabetes, Graves' disease, or Hashimoto's disease, or with medical monitor approval.
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Lustgarten Foundation: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

mitazalimab

Central Study Contacts

Abramson Cancer Center Clinical Trials Service

CONTACT

215-349-8245; PMCancerResearch@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)