Pancreatic CancerPhase 2NCT07415525
IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Borderline Resectable Pancreatic Cancer
A Phase 2 study testing IBI343 in people with Pancreatic Cancer and Borderline Resectable Pancreatic Adenocarcinoma, run by Zhejiang University at 1 site in China.
Trial summary
This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging and pathological diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Borderline Resectable Pancreatic Adenocarcinoma
- What is being tested?
- IBI343
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)Sign a written Informed Consent Form (ICF), willing and able to comply with the visits and related procedures specified in the protocol.
- (2)Histopathologically confirmed pancreatic adenocarcinoma.
- (3)No evidence of distant metastasis as assessed by imaging (must include chest, abdomen, and pelvis). Bone scan or PET/CT may be performed for confirmation if necessary.
- (4)Confirmed borderline resectable pancreatic cancer as assessed by imaging (abdominal contrast-enhanced CT or contrast-enhanced MRI), with resectability determined according to the NCCN 2025.V2 guidelines for pancreatic cancer.
- (5)No prior anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- (6)Age ≥18 years and ≤75 years, regardless of gender.
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- (7)Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- (8)Expected survival ≥12 weeks.
- (9)Adequate bone marrow and organ function.
- (10)Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment.
- (11)Confirmed *CLDN18.2 positivity by pathological tissue testing. *CLDN18.2 positivity is defined as Claudin18.2 immunohistochemical membrane staining intensity ≥1+ in ≥50% of tumor cells, accepting previous test results, results from the research center, or laboratory test results. Regarding the proportion of CLDN18.2 expression, the investigator and sponsor may dynamically adjust the criteria during the study based on newly generated data and data from other studies.
Who cannot join
- (1)Currently participating in another interventional clinical study, excluding observational (non-interventional) clinical studies or being in the survival follow-up phase of an interventional study.
- (2)The tumor is a locally recurrent lesion.
- (3)Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the investigational drug.
- (4)Underwent biliary stent implantation or PTCD within 7 days before the first dose of the investigational drug.
- (5)Received any live vaccine within 4 weeks before the first dose of the investigational drug or plans to receive one during the study period.
- (6)Underwent major surgical procedures (craniotomy, thoracotomy, laparotomy, or other surgeries defined by the investigator, excluding needle biopsy) within 4 weeks before the first dose of the investigational drug, or has unhealed wounds, ulcers, or fractures; or plans to undergo major surgery during the study period.
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- (7)History of gastrointestinal perforation and/or fistula within the past 6 months before the first dose of the investigational drug, which has not been resolved through surgical treatment.
- (8)Pyloric obstruction affecting eating or gastric emptying that cannot be improved by jejunal feeding tube placement.
- (9)Post-implantation of a stent in the digestive tract (referring to the muscular tube from the mouth to the anal canal, including the mouth, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum), and anal canal) or trachea. (Excluding stent placement included as part of radical surgery, such as duodenal stent placement in subjects with pancreatic head cancer.)
- (10)Interstitial lung disease requiring steroid treatment, or a history of interstitial lung disease, non-infectious pneumonia, severely impaired lung function, or uncontrolled pulmonary conditions such as pulmonary fibrosis, severe radiation pneumonitis, acute lung injury, etc., or suspicion of the above conditions during screening.
- (11)Presence of uncontrolled diseases.
- (12)History of other primary malignancies.
- (13)Known history of immunodeficiency.
- (14)History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- (15)Previously received antibody-drug conjugate therapy based on topoisomerase inhibitors.
- (16)For subjects receiving medication, a history of allergy to the corresponding drug or formulation.
- (17)For subjects receiving medication, contraindications to the corresponding drug.
- (18)For subjects receiving medication, a history of permanent discontinuation of the corresponding drug due to adverse reactions.
- (19)Pregnant or breastfeeding female subjects.
- (20)Other conditions considered by the investigator as not suitable for participation in 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.
China1 site
First Affiliated Hospital of Zhejiang University Schlool of Medicine, Hangzhou, Zhejiang
Hangzhou, Zhejiang, 310000
Yiwen Chen, +8619941463683, yiwenchen0705@126.com
About this study
Official title: A Phase II Clinical Study Evaluating the Safety and Efficacy of IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Subjects With Borderline Resectable Pancreatic Cancer
This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging and pathological diagnosis. Subjects will receive 4 cycles of neoadjuvant therapy. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy . Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy. Adjuvant therapy will begin 21-56 days post-surgery, and the total duration of preoperative neoadjuvant and postoperative adjuvant therapy will be 6 months. Subjects will continue adjuvant therapy until the planned treatment duration is completed, or until disease recurrence, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other treatment discontinuation criteria are met (whichever occurs first). After discontinuation of study treatment, subjects will undergo safety follow-up and survival follow-up.
Read the detailed description
This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging (contrast-enhanced CT or MRI) and pathological diagnosis. Subjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine). Adjuvant therapy will begin 21-56 days post-surgery, and the total duration of preoperative neoadjuvant and postoperative adjuvant therapy will be 6 months. Subjects will continue adjuvant therapy until the planned treatment duration is completed, or until disease recurrence, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other treatment discontinuation criteria are met (whichever occurs first). After discontinuation of study treatment, subjects will undergo safety follow-up and survival follow-up.
- Being tested
- IBI343
- Keywords
- borderline resectable pancreatic adenocarcinoma, Claudin 18.2 positive, neoadjuvant therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI343Drug
Also called AG regimen
Subjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine).
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Subjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine). Receives: Drug: IBI343 |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month Event-Free Survival (EFS) rate
The proportion of patients who had tumor progression, tumor recurrence (local, regional or distant) or death within 1 year after surgery, whichever occurred first
Measured: Up to one year
Secondary outcomes (6)
Event Free Survival, EFS
From treatment to the date of the first documented tumor progression, tumor into recurrence or death from any cause, whichever occurred first
Measured: Up to 2 years
Disease Control Rate (DCR)
The proportion of patients who have achieved a best response of either Stable Disease (SD), Partial Response (PR), or Complete Response (CR). It essentially measures the treatment's ability to stop the cancer from growing.
Measured: Up to 2 yeas
R0 resection rate
R0 resection rate is the percentage of patients who undergo a surgical procedure where the surgeon successfully removes the entire visible tumor and a microscopic examination confirms that no cancer cells are left at the edges (margins) of the removed tissue.
Measured: Up to 1 year
Objective Response Rate (ORR)
The proportion of patients whose tumor shrinks (responds) by a predefined amount from its baseline size for a minimum period of time. It includes two categories of response:
Complete Response (CR): The disappearance of all target tumors. Partial Response (PR): A specified minimum decrease (e.g., 30%) in the sum of the diameters of the target tumors.
Measured: Up to 2 years
Overall Survival (OS)
The length of time from a defined point in a study (e.g., date of randomization or start of treatment) until death from any cause.
Measured: Up to 3 yeas.
Adverse Event, AE
Occurence and frequence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)
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.
- First posted17 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415525
- Sponsor's protocol ID
- CISPD-12
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Evaluating the Safety and Efficacy of IBI343 Combined With Chemotherapy as Neoadjuvant Therapy in Subjects With Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07415525
- Acronym / sponsor ID
- CISPD-12
- Keywords
- borderline resectable pancreatic adenocarcinoma, Claudin 18.2 positive, neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Feb 2026 (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 study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging and pathological diagnosis. Subjects will receive 4 cycles of neoadjuvant therapy. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy . Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy. Adjuvant therapy will begin 21-56 days post-surgery, and the total duration of preoperative neoadjuvant and postoperative adjuvant therapy will be 6 months. Subjects will continue adjuvant therapy until the planned treatment duration is completed, or until disease recurrence, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other treatment discontinuation criteria are met (whichever occurs first). After discontinuation of study treatment, subjects will undergo safety follow-up and survival follow-up.
Detailed description
This study is a Phase II trial evaluating the safety and efficacy of IBI343 in combination with chemotherapy as neoadjuvant therapy for subjects with borderline resectable pancreatic cancer (BRPC). The study enrolls treatment-naïve subjects with CLDN18.2-positive BRPC, confirmed by imaging (contrast-enhanced CT or MRI) and pathological diagnosis. Subjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine). Adjuvant therapy will begin 21-56 days post-surgery, and the total duration of preoperative neoadjuvant and postoperative adjuvant therapy will be 6 months. Subjects will continue adjuvant therapy until the planned treatment duration is completed, or until disease recurrence, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or other treatment discontinuation criteria are met (whichever occurs first). After discontinuation of study treatment, subjects will undergo safety follow-up and survival follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: IBI343Subjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- (1)Sign a written Informed Consent Form (ICF), willing and able to comply with the visits and related procedures specified in the protocol.
- (2)Histopathologically confirmed pancreatic adenocarcinoma.
- (3)No evidence of distant metastasis as assessed by imaging (must include chest, abdomen, and pelvis). Bone scan or PET/CT may be performed for confirmation if necessary.
- (4)Confirmed borderline resectable pancreatic cancer as assessed by imaging (abdominal contrast-enhanced CT or contrast-enhanced MRI), with resectability determined according to the NCCN 2025.V2 guidelines for pancreatic cancer.
- (5)No prior anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
Key exclusion criteria (20 listed)
- (1)Currently participating in another interventional clinical study, excluding observational (non-interventional) clinical studies or being in the survival follow-up phase of an interventional study.
- (2)The tumor is a locally recurrent lesion.
- (3)Received treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) before the first dose of the investigational drug.
- (4)Underwent biliary stent implantation or PTCD within 7 days before the first dose of the investigational drug.
- (5)Received any live vaccine within 4 weeks before the first dose of the investigational drug or plans to receive one during the study period.
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 |
|---|---|---|
| IBI343Also: AG regimenSubjects will receive 4 cycles of neoadjuvant therapy with the following regimen: IBI343 6mg/kg IV D1 Q3W + Gemcitabine 800mg/m² IV D1, D8 Q3W + Nab-paclitaxel 100mg/m² IV D1, D8 Q3W. During or after neoadjuvant therapy, subjects who are unable to undergo radical surgical resection due to disease progression (based on RECIST v1.1) or other reasons will discontinue study treatment. After imaging assessment, subjects deemed eligible for radical resection by a multidisciplinary team (MDT) will undergo radical surgery 14-28 days after the last dose of neoadjuvant therapy (for subjects unable to undergo surgery within this window due to adverse events or other reasons, radical surgery must be performed no later than 42 days after the last dose of neoadjuvant therapy). Following surgery, subjects will receive adjuvant therapy with the AG regimen or investigator-selected adjuvant chemotherapy (gemcitabine monotherapy or gemcitabine combined with capecitabine). | Drug | treatment group |
Primary outcome
12-month Event-Free Survival (EFS) rate
Time frame: Up to one year
The proportion of patients who had tumor progression, tumor recurrence (local, regional or distant) or death within 1 year after surgery, whichever occurred first
6 secondary outcomes
Event Free Survival, EFS
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 yeas
R0 resection rate
Time frame: Up to 1 year
Objective Response Rate (ORR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 3 yeas.
Adverse Event, AE
Time frame: Up to 2 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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI343 in people with Pancreatic Cancer and Borderline Resectable Pancreatic Adenocarcinoma, run by Zhejiang University at 1 site in China.
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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 17 Feb 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 China. 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 Yiwen Chen, MD. (+8619941463683, yiwenchen0705@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month Event-Free Survival (EFS) rate (time frame: Up to one year). 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 17 Feb 2026.