Metastatic Pancreatic Ductal AdenocarcinomaPhase 1/2NCT07214298
Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 1/2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Pancreatic Ductal Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 1 Oct 2028
- 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
- Histologically or cytologically confirmed metastatic PDAC
- Age ≥ 18 years of age
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count ≥ 1,500/uL
- Platelets ≥ 100,000/uL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
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- Aspartate aminotransferase (AST)(serum oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN or <=5 ULN in the presence of liver metastasis
- Estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault equation)
- Albumin ≥ 3 g/dL
- Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
- All patients must either have available archival tumor tissue or undergo new tumor biopsy (if presence of a lesion that can be safely biopsied) before treatment initiation for correlative studies
- Willing and able to self-administer pegcetacoplan (administration by caregiver will be allowed)
- Willing to receive vaccination against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Women of child-bearing potential taking part in this study should continue the use of birth control for 6 months after the last study treatment, and should not donate eggs during that timeframe
- Male participants taking part in this study should continue the use of birth control for 3 months after the last study treatment, and should not donate sperm during that timeframe
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Previous chemotherapy for PDAC. Gemcitabine-based post- or pre-operative therapy is allowed provided that the last dose and or surgical resection was at least 6 months prior to the documentation of metastatic disease, whichever occurred last
- Toxicities from prior treatment grade > 1 with the exemption of alopecia and fatigue
- Refractory ascites or pleural effusion (requiring para- or thoracentesis weekly or more frequently or use of indwelling catheter for palliation)
- Untreated bowel or gastric outlet obstruction; patients with ≤ 6 weeks from such an event who are adequately palliated are allowed to participate
- Participants with known untreated brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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- Patients with major arterial thromboembolism (ATE) (coronary, cerebral, extremity or splanchnic) or venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis) within 6 months from initiation of study treatment are not eligible for participation
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Sarah Chatley, BS, 716-845-4846, Sarah.Chatley@RoswellPark.org
Christos Fountzilas
About this study
Official title: A Phase I/II Study of Complement Inhibition in Pancreatic Ductal Adenocarcinoma
This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and/or effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety oxaliplatin, irinotecan, leucovorin calcium (leucovorin), and fluorouracil (mFOLFIRINOX) in combination with pegcetacoplan in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). (Phase I) II. To identify preliminary signals of clinical efficacy of the study treatment. (Phase II)
SECONDARY OBJECTIVES:
- To evaluate the incidence of major thrombotic events and complications. II. To evaluate the efficacy (overall response rate, overall survival, disease control rate) of the combination treatment in the study population.
EXPLORATORY OBJECTIVES:
- To evaluate the effect of therapy on circulating biomarkers of neutrophil extracellular traps (NETs), endothelial cell injury, and cytokine responses.
II. For patients who agree to an optional on-treatment biopsy, the effects of therapy on innate and lymphocyte responses in the tumor microenvironment (TME) will be assessed.
III. To assess the ability of the combination to control or prevent malignant effusions (pleural or ascites fluid).
IV. To evaluate the pegcetacoplan levels in peripheral blood and other biological specimens.
OUTLINE:
Patients receive pegcetacoplan intravenously (IV) over 30 minutes on day 1 of cycle 1 and prior to mFOLFIRINOX and self-administered subcutaneously (SC) thrice weekly (every 2 days), when due on days in the office it will be given IV over 30 minutes prior to mFOLFIRINOX. Patients receive oxaliplatin IV over 2 hours, irinotecan and leucovorin IV concurrently over 90 minutes, and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo ascites, pleural fluid (if present) and blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Additionally, patients may undergo tumor biopsy throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 3 years.
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Fluorouracil, Irinotecan
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo ascites, pleural fluid and blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
IrinotecanDrug
Given IV
Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate
Given IV
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
OxaliplatinDrug
Also called 1-OHP, Ai Heng, Aiheng, Dacotin
Given IV
PegcetacoplanDrug
Also called APL 2, APL-2, APL2, Empaveli
Given IV and SC
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pegcetacoplan, mFOLFIRINOX) | Experimental | Patients receive pegcetacoplan IV over 30 minutes on day 1 of cycle 1 and prior to mFOLFIRINOX and self-administered SC thrice weekly (every 2 days), when due on days in the office it will be given IV over 30 minutes prior to mFOLFIRINOX. Patients receive oxaliplatin IV over 2 hours, irinotecan and leucovorin IV concurrently over 90 minutes, and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo ascites, pleural fluid (if present) and blood sample collection and CT or MRI throughout the study. Additionally, patients may undergo tumor biopsy throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Fluorouracil; Drug: Irinotecan; Drug: Leucovorin Calcium; Procedure: Magnetic Resonance Imaging; Drug: Oxaliplatin; Drug: Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related adverse events (AE) (Phase I)
Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria. Will be defined as any grade 3 or higher AE possibly, or definitely related to pegcetacoplan only. Will be summarized as the proportion of evaluable patients with 95% Clopper-Pearson confidence interval.
Measured: Up to 30 days after last dose of study treatment
Progression-free survival (Phase II)
Measured: From treatment initiation until disease progression, death or last disease assessment, assessed at 24 weeks
Secondary outcomes (4)
Overall response rate (ORR)
Will be defined as the percentage of patients who have achieved a partial response (PR) or complete response (CR) to the study therapy. The ORR will be summarized as proportions and 90% Clopper-Pearson confidence intervals.
Measured: Up to 3 years
Overall survival
Will be summarized using Kaplan-Meier estimator.
Measured: From treatment until death or last follow-up, assessed up to 3 years
Disease control rate (DCR)
Will be defined as the percentage of patients who have achieved CR, PR, or stable disease. The DCR will be summarized as proportions and 90% Clopper-Pearson confidence intervals.
Measured: Up to 3 years
Incidence of arterial thromboembolism/venous thromboembolism
The occurrence will be summarized as proportions and 90% Clopper-Pearson confidence intervals.
Measured: While on study treatment, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start16 Feb 2026
- Primary completion16 Feb 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christos Fountzilas, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214298
- Sponsor's protocol ID
- I-4316824
- Other IDs
- NCI-2025-06680, I-4316824
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Complement Inhibition in Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07214298
- Acronym / sponsor ID
- I-4316824
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 16 Feb 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and/or effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety oxaliplatin, irinotecan, leucovorin calcium (leucovorin), and fluorouracil (mFOLFIRINOX) in combination with pegcetacoplan in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). (Phase I) II. To identify preliminary signals of clinical efficacy of the study treatment. (Phase II)
SECONDARY OBJECTIVES:
- To evaluate the incidence of major thrombotic events and complications. II. To evaluate the efficacy (overall response rate, overall survival, disease control rate) of the combination treatment in the study population.
EXPLORATORY OBJECTIVES:
- To evaluate the effect of therapy on circulating biomarkers of neutrophil extracellular traps (NETs), endothelial cell injury, and cytokine responses.
II. For patients who agree to an optional on-treatment biopsy, the effects of therapy on innate and lymphocyte responses in the tumor microenvironment (TME) will be assessed.
III. To assess the ability of the combination to control or prevent malignant effusions (pleural or ascites fluid).
IV. To evaluate the pegcetacoplan levels in peripheral blood and other biological specimens.
OUTLINE:
Patients receive pegcetacoplan intravenously (IV) over 30 minutes on day 1 of cycle 1 and prior to mFOLFIRINOX and self-administered subcutaneously (SC) thrice weekly (every 2 days), when due on days in the office it will be given IV over 30 minutes prior to mFOLFIRINOX. Patients receive oxaliplatin IV over 2 hours, irinotecan and leucovorin IV concurrently over 90 minutes, and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo ascites, pleural fluid (if present) and blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Additionally, patients may undergo tumor biopsy throughout the study.
After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pegcetacoplan, mFOLFIRINOX) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Drug: Fluorouracil, Drug: Irinotecan, Drug: Leucovorin Calcium, Procedure: Magnetic Resonance Imaging, Drug: Oxaliplatin, Drug: PegcetacoplanPatients receive pegcetacoplan IV over 30 minutes on day 1 of cycle 1 and prior to mFOLFIRINOX and self-administered SC thrice weekly (every 2 days), when due on days in the office it will be given IV over 30 minutes prior to mFOLFIRINOX. Patients receive oxaliplatin IV over 2 hours, irinotecan and leucovorin IV concurrently over 90 minutes, and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo ascites, pleural fluid (if present) and blood sample collection and CT or MRI throughout the study. Additionally, patients may undergo tumor biopsy throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed metastatic PDAC
- Age ≥ 18 years of age
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count ≥ 1,500/uL
- Platelets ≥ 100,000/uL
Key exclusion criteria (10 listed)
- Previous chemotherapy for PDAC. Gemcitabine-based post- or pre-operative therapy is allowed provided that the last dose and or surgical resection was at least 6 months prior to the documentation of metastatic disease, whichever occurred last
- Toxicities from prior treatment grade > 1 with the exemption of alopecia and fatigue
- Refractory ascites or pleural effusion (requiring para- or thoracentesis weekly or more frequently or use of indwelling catheter for palliation)
- Untreated bowel or gastric outlet obstruction; patients with ≤ 6 weeks from such an event who are adequately palliated are allowed to participate
- Participants with known untreated brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo tumor biopsy | Procedure or surgery | Treatment (pegcetacoplan, mFOLFIRINOX) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo ascites, pleural fluid and blood sample collection | Procedure or surgery | Treatment (pegcetacoplan, mFOLFIRINOX) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (pegcetacoplan, mFOLFIRINOX) |
| FluorouracilAlso: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedioneGiven IV | Drug | Treatment (pegcetacoplan, mFOLFIRINOX) |
| IrinotecanGiven IV | Drug | Treatment (pegcetacoplan, mFOLFIRINOX) |
| Leucovorin CalciumAlso: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium FolinateGiven IV | Drug | Treatment (pegcetacoplan, mFOLFIRINOX) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (pegcetacoplan, mFOLFIRINOX) |
| OxaliplatinAlso: 1-OHP, Ai Heng, Aiheng, DacotinGiven IV | Drug | Treatment (pegcetacoplan, mFOLFIRINOX) |
| PegcetacoplanAlso: APL 2, APL-2, APL2, EmpaveliGiven IV and SC | Drug | Treatment (pegcetacoplan, mFOLFIRINOX) |
Primary outcome
Incidence of treatment-related adverse events (AE) (Phase I)
Time frame: Up to 30 days after last dose of study treatment
Will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria. Will be defined as any grade 3 or higher AE possibly, or definitely related to pegcetacoplan only. Will be summarized as the proportion of evaluable patients with 95% Clopper-Pearson confidence interval.
Progression-free survival (Phase II)
Time frame: From treatment initiation until disease progression, death or last disease assessment, assessed at 24 weeks
4 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 3 years
Overall survival
Time frame: From treatment until death or last follow-up, assessed up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Incidence of arterial thromboembolism/venous thromboembolism
Time frame: While on study treatment, assessed up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christos Fountzilas principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Pancreatic Ductal Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Roswell Park Cancer Institute 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 17 inclusion and 10 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 19 Aug 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 Sarah Chatley, BS (716-845-4846, Sarah.Chatley@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related adverse events (AE) (Phase I) (time frame: Up to 30 days after last dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.