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Borderline Resectable Pancreatic AdenocarcinomaPhase 1/2NCT05688215

Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Core Biopsy in people with Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, run by Jonsson Comprehensive Cancer Center 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

This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Core Biopsy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
7 Mar 2023to 2 Mar 2027
Phase
Phase 1/2
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

  • Male or female >= 18 years of age and willing and able to provide informed consent
  • Previously untreated cytologically or histologically confirmed pancreatic adenocarcinoma with one of the following:
  • Borderline resectable disease. There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as the presence of any one or more of the following on CT;
  • An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring >= 180 degrees of the circumference of the vessel wall
  • Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction
  • Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction
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  • An interface between the tumor and SMA measuring < 180 degrees of the circumference of the vessel wall
  • Locally advanced disease. Multiple guidelines defining locally advanced PDAC have been developed, including the MD Anderson definition, the National Comprehensive Cancer Network (NCCN) definition, as well as the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Locally advanced PDAC cases will be identified per the definition developed by the Alliance for Clinical Trials in Oncology. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT;
  • Occlusion of the SMV-PV that is not amenable to resection and venous reconstruction
  • Interface between tumor and hepatic artery that is not amenable to resection and reconstruction
  • Interface between the tumor and SMA measuring > 180 degrees of the circumference of the vessel wall
  • Interface between the tumor and celiac axis measuring > 180 degrees of the circumference of the vessel wall
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • Platelets >= 100 x 10^9/L
  • Hemoglobin >= 9 g/dL
  • Serum creatinine (sCr) =< 1.5 x upper limit of normal (ULN) or Creatinine clearance (Ccr) >= 40 mL/min (as calculated by Modified Cockcroft-Gault formula)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (AST/[SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN
  • Women with no childbearing potential because of surgery or who are at least 1 year postmenopausal (ie, 12 months post last menstrual period) or with menopause confirmed by follicle-stimulating hormone testing
  • Women of childbearing potential must use an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; or vasectomized male partner if he is the sole partner of that participant) for the duration of the study and for up to 6 months after the last dose of zimberelimab or quemliclustat
  • Male participants must use an effective method of contraception (condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository, or vasectomy) throughout the study and for up to 6 months after the last dose of zimberelimab or quemliclustat
  • Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study treatment administration. Physiologic doses of corticosteroids (=< 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (=< 3 days) may be permitted
  • Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before study treatment administration. Surgery requiring regional/epidural anesthesia must be completed at least 72 hours before study treatment administration. Participants should have recovered from the surgical procedure prior to the first dose being administered

Who cannot join

  • Recurrent or metastatic pancreatic adenocarcinoma
  • Peripheral neuropathy > grade 2
  • Known status of human immunodeficiency virus (HIV) which is not well-controlled (CD4 <300) at the time of study eligibility. Patients with controlled and treated HIV/Hepatitis C virus (HCV) and an undetectable viral load are allowed
  • Untreated Hepatitis B infection: Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local regulation)
  • Participants with resolved or treated HCV (ie, HCV antibody positive but undetectable HCV ribonucleic acid [RNA]) will not be excluded from this study
  • Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational products (IPs) hazardous, including but not limited to:
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  • Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis (lymphangitic spread of non-small cell lung cancer (NSCLC) is not disqualifying)
  • Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of the IP
  • Active infection or antibiotics within 48 hours prior to study screening
  • Clinically significant cardiovascular disease
  • A condition or unresolved adverse event (AE) from a prior investigational drug that may obscure the interpretation of toxicity determination or AEs
  • History of prior solid-organ transplantation
  • Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)
  • Serious medical comorbidities such as New York Heart Association Class III/IV cardiac disease, uncontrolled cardiac arrhythmias, myocardial infarction over the past 12 months
  • Known, existing uncontrolled coagulopathy. Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation are eligible IF: they are appropriately anticoagulated and have not had a Grade 2 or greater bleeding episode in the 3 weeks before Day 1
  • Known pregnancy, nursing women or positive pregnancy test. Requirement for women of child-bearing potential (WOCBP): Negative serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1, within 24 hours prior to the start of treatment (minimum sensitivity 25 IU/L or equivalent units of HCG). WOCBP must also have a negative serum or urine pregnancy test every 4 weeks, within 24 hours prior to the start of treatment
  • Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator
  • History of trauma or major surgery within 28 days prior to the first dose of IP
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Any active or documented history of autoimmune disease, including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment, except for the following:
  • Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger
  • Endocrinopathies where the participant is stable on hormone replacement therapy
  • History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone
  • History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study

Trial locations and contacts

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

Lisa Yonemoto contact

3105824069

LYonemoto@mednet.ucla.edu

United States1 site, 1 recruiting

  • Yonemoto,Lisa

    Los Angeles, California, 90095

    Lisa A. Yonemoto, 3105824069, LYonemoto@mednet.ucla.edu

    Zev A. Wainberg, MD

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study of Zimberelimab and Quemliclustat Combination With Chemotherapy in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat acts as a blocker for adenosine. Adenosine is a chemical produced in the body that can lead to a decrease in the immune system's response towards cancer. Quemliclustat has the potential to decrease the amount of adenosine, allowing the immune system to recognize and act against the cancer. Chemotherapy drugs, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy in combination with zimberelimab and quemliclustat may kill more cancer cells than chemotherapy alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety, tolerability and resection rate (for borderline resectable pancreatic cancer [BRPC] cohort) or progression free survival (PFS) (for locally advanced pancreatic cancer [LAPC] cohort) in patients with borderline resectable pancreatic cancer (BRPC) or locally advanced pancreatic cancer (LAPC) treated with modified fluorouracil, irinotecan, leucovorin and oxaliplatin (mFOLFIRINOX), quemliclustat, and zimberelimab.

II. To evaluate development of clinically relevant pancreatic fistula (for BRPC cohort) in the post-operative period after neoadjuvant treatment with mFOLFIRINOX, quemliclustat, and zimberelimab.

SECONDARY OBJECTIVES:

  1. To estimate efficacy as measured by decreases in CA 19-9 and objective response rate (ORR) by imaging (unconfirmed complete and partial responses).

II. To estimate the pathologic complete response rate (pCR) (for BRPC cohort) and overall survival (OS).

EXPLORATORY OBJECTIVES:

  1. To evaluate the effects of zimberelimab, quemliclustat, and modified FOLFIRINOX (mFFX) on the tumor-stromal cells comparing pre-treatment core biopsies with operative specimens and on the effects on T cell infiltration, PD1 expression and the tumor microenvironment (TME).

II. To investigate potential serum and tumor predictive biomarkers to predict response to experimental therapy.

OUTLINE:

Patients receive zimberelimab intravenously (IV), quemliclustat IV, oxaliplatin IV, leucovorin calcium IV, and inrinotecan IV on study. Patients undergo collection of blood samples and computed tomography (CT) throughout the trial. Patients with borderline-resectable pancreatic cancer undergo collection of tissue samples. Patients with locally advanced pancreatic cancer undergo core biopsy.

Being tested
Biospecimen Collection, Computed Tomography, Core Biopsy, Fluorouracil, Irinotecan

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood and tissue samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo a CT scan

  • Core BiopsyProcedure or surgery

    Also called BIOPSY, CORE, CNB, Core Needle, Core Needle Biopsy

    Undergo core biopsy

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given IV

  • IrinotecanDrug

    Given IV

  • LeucovorinDrug

    Also called Folinic acid

    Given IV

  • Leucovorin CalciumDrug

    Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate

    Given IV

  • OxaliplatinDrug

    Also called 1-OHP, Ai Heng, Aiheng, Dacotin

    Given IV

  • QuemliclustatDrug

    Also called AB 680, AB-680, AB680, CD73 Inhibitor AB680

    Given intravenously (IV)

  • ZimberelimabDrug

    Also called AB 122, AB-122, AB122, Anti-PD-1 Monoclonal Antibody GLS-010

    Given IV

Study groups in NCT05688215
Study groupRoleWhat they receive
Treatment (zimberelimab, quemliclustat, chemotherapy)ExperimentalPatients receive zimberelimab IV, quemliclustat IV, oxaliplatin IV, leucovorin calcium IV, and inrinotecan IV on study. Patients undergo collection of blood samples and CT throughout the trial. Patients with borderline-resectable pancreatic cancer undergo collection of tissue samples. Patients with locally advanced pancreatic cancer undergo core biopsy.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Core Biopsy; Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin; Drug: Leucovorin Calcium; Drug: Oxaliplatin; Drug: Quemliclustat; Drug: Zimberelimab

What is being measured

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

  1. Incidence of adverse events (BPRC Cohort)

    All safety summaries and analyses will be based upon the Safety Population, as defined in this study protocol, will include all randomized participants who receive at least 1 dose of any study drug. Overall exposure to study drug, the numbers of participants completing each cycle, and the dose intensity will be summarized using descriptive statistics. The number of participants with any dose adjustment will be presented for entire treatment period as well as for each cycle. The number of participants with dose reductions, dose delays, or dose omissions will also be summarized, as will the reasons for dose adjustments. Adverse events (AEs) and serious adverse events (SAEs) will be reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 terminology and severity.

    Measured: From baseline measurement to 90 days after the last dose of study treatment.

  2. Resection rate (BPRC Cohort)

    Simon's two-stage design will be used to demonstrate the resection rate is greater than 50%.

    Measured: Up to 2 years

  3. Progression free survival (PFS) (LAPC Cohort)

    Descriptive statistics with frequency and proportion will be used to summarize R0 resection rate and PFS. Kaplan-Meier methods will be used to analyze PFS and to generate 95% confidence interval (CI).

    Measured: Up to 2 years

  4. Number of participants who develop clinically relevant pancreatic fistula (BPRC Cohort)

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Change in CA 19-9 levels

    Measured: Up to 30 days after last study drug administration

  2. Objective response rate (ORR)

    Descriptive statistics with frequency and proportion used to analyze. Assessed by imaging.

    Measured: Up to 2 years

  3. Pathologic complete response rate (pCR) (BPRC Cohort)

    Measured: Up to 2 years

  4. Overall survival (OS)

    Descriptive statistics with frequency and proportion will be used to analyze.

    Measured: Up to 2 years

Timeline

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

  1. First posted18 Jan 2023
  2. Study start7 Mar 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion2 Mar 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688215
Sponsor's protocol ID
22-001565
Other IDs
NCI-2022-10208
Status last verified
May 2026
First submitted
3 Jan 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Core Biopsy in people with Borderline Resectable Pancreatic Adenocarcinoma and Locally Advanced Pancreatic Ductal Adenocarcinoma, run by Jonsson Comprehensive Cancer Center 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 23 inclusion and 24 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 29 Oct 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Lisa Yonemoto (3105824069, LYonemoto@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (BPRC Cohort) (time frame: From baseline measurement to 90 days after the last dose of study treatment.). The study lists 4 primary outcomes in all. 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 NCT05688215.

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 29 Oct 2026.

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