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Pancreatic Ductal AdenocarcinomaPhase 2IGNITENCT07199764

Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer

A Phase 2 study testing Odetiglucan and Mitazalimab in people with Pancreatic Ductal Adenocarcinoma, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 4-8 months of first line (1L) chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Odetiglucan and Mitazalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
25 Nov 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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 32 weeks) is sufficient; confirmation is not required. If chemotherapy was discontinued between 16-32 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).
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Abramson Cancer Center Clinical Trials Service contact

215-349-8245

PMCancerResearch@pennmedicine.upenn.edu

United States1 site, 1 recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

Other trials in United States

About this study

Official title: IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma

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.

Read the detailed description

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.

The protocol incorporates an initial safety run-in phase evaluating dose-limiting (DLTs) over the first 21 days (Cycle 1), followed by a full Phase II efficacy evaluation. The safety run-in will enroll an initial cohort of 3 patients at the recommended Phase 2 dose (RP2D) for both odetiglucan and mitazalimab; if no DLTs occur, the study progresses to full enrollment. If DLTs occur, the cohort will expand to 6 patients with protocol-defined criteria for dose modification or de-escalation.

The study includes three treatment cohorts and an observational cohort.

Treatment Cohorts:

  • Cohort A: 26 patients with metastatic PDA achieving partial response (PR) on 1L chemotherapy
  • Cohort B: 12 patients with metastatic PDA achieving stable disease (SD) on 1L chemotherapy
  • Cohort C: 12 patients with locally advanced PDA achieving disease stability (PR or SD) on 1L chemotherapy

Observational Cohort:

An observational cohort of approximately 50-60 patients will be included, divided into three subgroups corresponding to the eligibility criteria of Cohorts A, B, and C:

  • Observational Subgroup A: 26-30 patients
  • Observational Subgroup B: 12-15 patients
  • Observational Subgroup C: 12-15 patients

The observational cohort will include patients who meet eligibility criteria but do not receive the study intervention, either due to declining participation in the treatment arm or through retrospective chart review.

Total enrollment will be 50 patients in the treatment arm and approximately 50-60 patients in the observational cohort.

Being tested
Odetiglucan, Mitazalimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OdetiglucanDrug

    Odetiglucan 4 mg/kg IV every 3 weeks

  • MitazalimabDrug

    Mitazalimab 0.9 mg/kg IV every 3 weeks

Study groups in NCT07199764
Study groupRoleWhat they receive
Cohort AExperimentalPatients with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
Receives: Drug: Odetiglucan; Drug: Mitazalimab
Cohort BExperimentalPatients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
Receives: Drug: Odetiglucan; Drug: Mitazalimab
Cohort CExperimentalPatients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
Receives: Drug: Odetiglucan; Drug: Mitazalimab
Prospective Cohort ANo interventionObservational Prospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
Prospective Cohort BNo interventionObservational Prospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
Prospective Cohort CNo interventionObservational Prospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy
Retrospective Cohort ANo interventionObservational Retrospective patient with metastatic pancreatic adenocarcinoma achieving a partial response (PR) on 1L chemotherapy
Retrospective Cohort BNo interventionObservational Retrospective Patients with metastatic adenocarcinoma achieving stable disease (SD) on 1L chemotherapy
Retrospective Cohort CNo interventionObservational Retrospective Patients with locally advanced pancreatic adenocarcinoma who have achieved disease stability partial response (PR) or stable disease (SD) on 1L chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7.5 months

Secondary outcomes (13)

  1. Safety and tolerability of maintenance odetiglucan/mitazalimab

    To evaluate safety and tolerability of maintenance odetiglucan/mitazalimab. Safety assessed by CTCAE v5.0 criteria.

    Measured: 19.5 months

  2. 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.

    Measured: 7.5 months

  3. 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

    Measured: 7.5 months

  4. 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

    Measured: 19.5 months

  5. Disease control rate (DCR) (Cohorts A-C)

    To estimate efficacy parameters of maintenance odetiglucan/mitazalimab in all patients (Cohorts A-C) by assessing disease control rate (DCR) using RECIST v1.1 and iRECIST

    Measured: 19.5 months

  6. Duration of response (DOR) (Cohorts A-C)

    To estimate efficacy parameters of maintenance odetiglucan/mitazalimab in all patients (Cohorts A-C) by assessing duration of response (DOR) from first response to progression or death from any cause

    Measured: 19.5 months

  7. Overall survival (OS) (Cohorts A-C)

    To estimate efficacy parameters of maintenance odetiglucan/mitazalimab in all patients (Cohorts A-C) by assessing overall survival (OS) from treatment initiation

    Measured: 19.5 months

  8. 1-yr Overall survival (OS) rate (Cohorts A-C)

    To estimate efficacy parameters of maintenance odetiglucan/mitazalimab in all patients (Cohorts A-C) by assessing 1-yr OS rate

    Measured: 19.5 months

  9. Overall response rate (ORR) between Treatment and Observational Arms

    Comparison of ORR between each treatment cohort and their corresponding observational subgroups

    Measured: 19.5 months

  10. Disease control rate (DCR) between Treatment and Observational Arms

    Comparison of DCR between each treatment cohort and their corresponding observational subgroups

    Measured: 19.5 months

  11. Duration of response (DOR) between Treatment and Observational Arms

    Comparison of DOR between each treatment cohort and their corresponding observational subgroups

    Measured: 19.5 months

  12. Overall survival (OS) between Treatment and Observational Arms

    Comparison of OS between each treatment cohort and their corresponding observational subgroups

    Measured: 19.5 months

  13. 1-yr Overall survival (OS) rate between Treatment and Observational Arms

    Comparison of 1-yr OS between each treatment cohort and their corresponding observational subgroups

    Measured: 19.5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2025
  2. Study start25 Nov 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07199764
Sponsor's protocol ID
859213
Acronym
IGNITE
Status last verified
Jun 2026
First submitted
22 Sep 2025
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Odetiglucan and Mitazalimab in people with Pancreatic Ductal Adenocarcinoma, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Abramson Cancer Center Clinical Trials Service (215-349-8245, PMCancerResearch@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median progression-free survival (mPFS) of 7.5 months in Cohort A (time frame: 7.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07199764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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