Pancreatic Ductal AdenocarcinomaPhase 1NCT07024615
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
A Phase 1 study testing ASP2138, Oxaliplatin and Leucovorin in people with Pancreatic Ductal Adenocarcinoma, run by Astellas Pharma Global Development, Inc. at 3 sites in United States.
Trial summary
Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. 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?
- ASP2138, Oxaliplatin and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Oct 2025to 31 Jan 2028
- Phase
- Phase 1
- 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
- Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma cannot have received any prior therapy.
- Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing may be allowed after discussion with the medical monitor, if results are pending or a biopsy for CLDN18.2 testing is not clinically appropriate). Site should contact the sponsor to assess potential eligibility based on a local test result.
- Participant has an available pretreatment tumor sample, if clinically appropriate and meets requirements.
- Participant is able to undergo surgery and treatment with adjuvant chemotherapy per institutional standard of care.
- Participant with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function of class 2B or better using the New York Heart Association Functional Classification.
- Female participant is not pregnant and at least 1 of the following conditions apply:
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- Not a woman of childbearing potential (WOCBP)
- WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy package insert [PI]/prescribing information, whichever is longer).
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (6 months) after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
- Female participant must not donate ova starting at first administration of neoadjuvant ASP2138, throughout the investigational period, and for 6 months after final ASP2138 administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
- Male participant must not donate sperm during the treatment period and for 6 months after ASP2138 intervention administration (or follow the contraception requirements per the adjuvant chemotherapy PI/prescribing information, whichever is longer).
- Participant has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to the first dose of study intervention per investigator assessment.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participant has a corrected QT interval by Fridericia (QTcF) ≤ 470 msec.
- Participant must meet all of the criteria based on laboratory tests within 7 days prior to the first dose of study intervention. Participant has adequate organ and marrow function. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 1 week after any blood transfusion.
- Participant agrees not to participate in another interventional study while receiving study intervention in the present study.
Who cannot join
- Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
- Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.
- Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.
- Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.
- Participant has another malignancy for which treatment is required.
- Participant has a history or complication of interstitial lung disease.
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- Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
- Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. NOTE: Applicable if participant is receiving fluoropyrimidine containing chemotherapy. Screening for DPD deficiency should be conducted per local requirements.
- Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with full dose warfarin (coumadin) is not allowed.
- Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).
- Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade ≥ 2 bleeding events in the month prior to treatment).
- Participant has uncontrolled intercurrent illness or infection.
- Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with cluster of differentiation (CD) 4+ T cell counts ≥ 350 cells/µL and no history of acquired immunodeficiency syndrome (AIDS) defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for HIV infection should be conducted per local requirements.
- Participant is known to have active hepatitis B (positive hepatitis B surface antigen [hBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted per local requirements.
- For participant who is negative for hBsAg, but hepatitis B core (HBc) Ab positive, an HBV DNA test will be performed and if positive the participant will be excluded.
- Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.
- Participant treated for HCV with undetectable viral load results is eligible.
- Participant has a known history of UGT1A1 gene polymorphism resulting in complete loss of function of the UGT1A1 gene product (for participants receiving irinotecan containing chemotherapy).
- Participant has any pre-existing severe gastric conditions such as active gastritis or ulcer that could be exacerbated by treatment.
- Participant has received any prior chemotherapy, radiation therapy, immunotherapy, or biologic ("targeted") therapy or investigational therapy for treatment of the participant's pancreatic tumor.
- Participant has received a live vaccine within 30 days of planned start of study therapy. NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.
- Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.
- Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.
- Participant has had a major surgical procedure 28 days before start of study intervention and has not fully recovered.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Duke University Medical Center - Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery.
In this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine.
People will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- ASP2138, Oxaliplatin, Leucovorin, 5-FU, Irinotecan
- Keywords
- Claudin (CLDN) 18.2, ASP2138, Safety, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2138Drug
Subcutaneously
OxaliplatinDrug
Injection
LeucovorinDrug
Also called Folinic Acid
Injection
5-FUDrug
Also called Fluorouracil
Injection
IrinotecanDrug
Injection
GemcitabineDrug
Intravenously
Nab-paclitaxelDrug
Intravenously
CapecitabineDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASP2138 and investigator's choice of adjuvant chemotherapy | Experimental | Participants will receive ASP2138 for up to 2 weeks prior to surgery. Following surgery participants will receive adjuvant chemotherapy (either mFOLFIRINOX [modified leucovorin (folinic acid), 5-FU (fluorouracil), irinotecan and oxaliplatin], Gemcitabine/Nab-paclitaxel, or Gemcitabine/Capecitabine) for up to 6 months or until meeting treatment discontinuation criteria. Receives: Drug: ASP2138; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-FU; Drug: Irinotecan; Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Measured: Up to 11.5 months
Number of participants with Serious Adverse Events (SAEs)
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations.
Measured: Up to 11.5 months
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 11.5 months
Number of participants with vital signs abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 11.5 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant 12-Lead ECG values.
Measured: Up to 10.5 months
Number of participants with physical examinations (PEs) abnormalities and/or AEs
Number of participants with potentially clinically significant PEs values.
Measured: Up to 11.5 months
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Measured: Up to 11.5 months
Number of participants with ASP2138-related surgery delays (≥ 7 days)
Surgery delay is defined as the interval (in days) between the pre-specified planned date of surgery and the actual date on which surgery is performed. Delays of ≥ 7 days that are assessed by the investigator as being related to ASP2138 (treatment-related) will be documented.
Measured: Up to 12 weeks after the end of neoadjuvant treatment
Secondary outcomes (4)
Pharmacokinetics (PK) of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the pharmacokinetic (PK) serum samples collected.
Measured: Up to 0.5 month
Number of participants at each grade of Pathologic Response
The College of American Pathologists (CAP) grading will be used to assess pathological response. Grades range from 0: No viable cancer cells (complete response) to grade 3: Extensive residual cancer with no evident tumor regression (poor or no response)
Measured: Up to 10.5 months
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the time from date of surgical resection of pancreas tumor until the date of radiological disease recurrence or death due to any cause
Measured: Up to 11.5 months
Number of participants with microscopically margin-negative (R0) resection
Measured: Up to 10.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Oct 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Associate Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024615
- Sponsor's protocol ID
- 2138-CL-0102
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
- ClinicalTrials.gov ID
- NCT07024615
- Acronym / sponsor ID
- 2138-CL-0102
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Claudin (CLDN) 18.2, ASP2138, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 17 Jun 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.
Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery.
In this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine.
People will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASP2138 and investigator's choice of adjuvant chemotherapy | Experimental | Drug: ASP2138, Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-FU, Drug: Irinotecan, Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: CapecitabineParticipants will receive ASP2138 for up to 2 weeks prior to surgery. Following surgery participants will receive adjuvant chemotherapy (either mFOLFIRINOX [modified leucovorin (folinic acid), 5-FU (fluorouracil), irinotecan and oxaliplatin], Gemcitabine/Nab-paclitaxel, or Gemcitabine/Capecitabine) for up to 6 months or until meeting treatment discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Participant has histologically confirmed localized pancreatic adenocarcinoma which is deemed upfront resectable based on institutional multi-disciplinary review. Participant with localized pancreatic adenocarcinoma cannot have received any prior therapy.
- Participant has confirmation of positive claudin (CLDN)18.2 test result by local laboratory prior to first dose of study intervention (ASP2138 dosing may be allowed after discussion with the medical monitor, if results are pending or a biopsy for CLDN18.2 testing is not clinically appropriate). Site should contact the sponsor to assess potential eligibility based on a local test result.
- Participant has an available pretreatment tumor sample, if clinically appropriate and meets requirements.
- Participant is able to undergo surgery and treatment with adjuvant chemotherapy per institutional standard of care.
- Participant with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function of class 2B or better using the New York Heart Association Functional Classification.
Key exclusion criteria (24 listed)
- Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.
- Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention.
- Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of study intervention.
- Participant has uncontrolled serious psychiatric illness or social situations that would preclude study compliance.
- Participant has another malignancy for which treatment is required.
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 |
|---|---|---|
| ASP2138Subcutaneously | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| OxaliplatinInjection | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| LeucovorinAlso: Folinic AcidInjection | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| 5-FUAlso: FluorouracilInjection | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| IrinotecanInjection | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| GemcitabineIntravenously | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| Nab-paclitaxelIntravenously | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
| CapecitabineOral | Drug | ASP2138 and investigator's choice of adjuvant chemotherapy |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to 11.5 months
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to 11.5 months
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations.
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to 11.5 months
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital signs abnormalities and/or AEs
Time frame: Up to 11.5 months
Number of participants with potentially clinically significant vital sign values.
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 10.5 months
Number of participants with potentially clinically significant 12-Lead ECG values.
Number of participants with physical examinations (PEs) abnormalities and/or AEs
Time frame: Up to 11.5 months
Number of participants with potentially clinically significant PEs values.
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score
Time frame: Up to 11.5 months
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Number of participants with ASP2138-related surgery delays (≥ 7 days)
Time frame: Up to 12 weeks after the end of neoadjuvant treatment
Surgery delay is defined as the interval (in days) between the pre-specified planned date of surgery and the actual date on which surgery is performed. Delays of ≥ 7 days that are assessed by the investigator as being related to ASP2138 (treatment-related) will be documented.
4 secondary outcomes
Pharmacokinetics (PK) of ASP2138 in serum: concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Up to 0.5 month
Number of participants at each grade of Pathologic Response
Time frame: Up to 10.5 months
Disease-free survival (DFS)
Time frame: Up to 11.5 months
Number of participants with microscopically margin-negative (R0) resection
Time frame: Up to 10.5 months
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 2 Sep 2026.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Associate Medical Director study director
Astellas Pharma Global Development, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP2138, Oxaliplatin and Leucovorin in people with Pancreatic Ductal Adenocarcinoma, run by Astellas Pharma Global Development, Inc. at 3 sites 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 18 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
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 Astellas Pharma Global Development, Inc. (800-888-7704, Astellas.registration@astellas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: Up to 11.5 months). The study lists 8 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 2 Sep 2026.