Advan'ce'dPhase 1/2NCT07361991

IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer

A Phase 1/2 study testing IBI363, Bevacizumab and Nab-paclitaxel in people with Advan'ce'd and Advanced, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

This study is for patients with advanced or metastatic gastric cancer whose disease has worsened after first-line systemic therapy. IBI363 is an investigational antibody that may help the immune system recognize and attack cancer cells. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advan'ce'd, Advanced
What is being tested?: IBI363, Bevacizumab and Nab-paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: Mar 2026to Sep 2030
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent: The patient must voluntarily sign a written informed consent form and be able to comply with the visit schedule and procedures specified in the protocol.
Age: 18 to 75 years (inclusive), male or female.
Diagnosis and prior therapy:
Histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma (GC or GEJC).
Disease progression or intolerance after prior first-line systemic antitumor therapy including immunotherapy.
Primary immune resistance: best response during immunotherapy is stable disease (SD) lasting < 12 weeks, or progressive disease (PD).

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Acquired immune resistance:
1. For patients with PD on immunotherapy: best response during treatment is complete response (CR), partial response (PR), or SD lasting ≥ 12 weeks; 2. For patients who discontinued immunotherapy for reasons other than disease progression and subsequently developed PD: best response during treatment is CR, PR, or SD lasting ≥ 12 weeks, and the interval between last immunotherapy dose and PD is ≤ 6 months.
4. Baseline hematology (within 7 days before first dose of study drug) must meet all of the following:
Hemoglobin ≥ 90 g/L;
Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L;
Platelet count ≥ 100 × 10⁹/L;
Eosinophils < 1.5 × upper limit of normal (ULN).
In this protocol, "baseline" is defined as the last available assessment prior to the first dose of study drug. Within 7 days before blood sampling, patients must not receive blood products (including packed red blood cells, apheresis platelets, cryoprecipitate, etc.), erythropoiesis-stimulating agents, or colony-stimulating factor support.
5. Baseline serum chemistry (within 7 days before first dose) must meet all of the following:
Total bilirubin ≤ 1.5 × ULN (patients with total bilirubin > 1.5 × ULN are allowed if conjugated bilirubin ≤ ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN;
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 45 mL/min, calculated by the Cockcroft-Gault formula using actual body weight;
Serum albumin ≥ 32 g/L.
6. Baseline coagulation function (within 7 days before first dose) must meet all of the following:
International normalized ratio (INR) ≤ 1.5 × ULN (≤ 3 × ULN if on stable anticoagulation therapy);
Partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (≤ 3 × ULN if on stable anticoagulation therapy).
7. Baseline urinalysis (within 7 days before first dose)must meet one of the following:
Urine protein (UPRO) < 2+ by dipstick, or
24-hour urine protein < 1 g.
8. At least one measurable lesion as defined by RECIST v1.1 for solid tumors.
9. ECOG performance status of 0 or 1 (Eastern Cooperative Oncology Group).
10. Estimated life expectancy ≥ 3 months.
11. Contraception: Women of childbearing potential and men whose partners are women of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the last dose of study treatment.

Who cannot join

Pregnant or breastfeeding women, or women planning to become pregnant before the first dose of study drug, during study treatment, or within 6 months after the last dose.
History of active thrombosis, deep venous thrombosis, or pulmonary embolism within 4 weeks before the first dose of study drug, unless adequately treated and considered clinically stable by the investigator.
Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:
Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., anti-arrhythmic therapy);
Severe conduction abnormalities (e.g., third-degree atrioventricular block);
QT interval corrected by Fridericia (QTcF) ≥ 480 ms;

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Uncontrolled arterial hypertension despite optimal medical therapy (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);
History of myocarditis;
Current congestive heart failure requiring treatment;
Left ventricular ejection fraction (LVEF) < 50%;
New York Heart Association (NYHA) class III or IV heart failure;
Acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent implantation within 6 months prior to the first dose;
Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose;
Known active seizure disorders.
Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other forms of restrictive lung disease that require corticosteroids or other treatment, or a history of severely impaired pulmonary function.
History of atopic constitution, asthma, or atopic dermatitis.
Clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated drainage or associated with significant symptoms.
Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose of study drug. Replacement therapy (e.g., thyroxine, insulin, or physiological replacement doses of corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.
History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Known hypersensitivity or allergy to study drugs or any of their excipients.
History of significant toxicities related to prior immune checkpoint inhibitor therapy that required permanent discontinuation of that treatment.
Unresolved toxicities from prior antitumor therapies > Grade 1 (based on NCI CTCAE), with the exception of the following: persistent Grade 2 alopecia, peripheral neuropathy, hypomagnesemia, or other toxicities that are expected to be irreversible but are stable under medical management (e.g., hypothyroidism controlled with replacement therapy, hypertension controlled to <160/100 mmHg with antihypertensive medications).
Incomplete recovery from prior surgery, or having undergone any major surgery within 4 weeks before the first dose of study drug.
Active, uncontrolled bleeding or known bleeding diathesis.
Major gastrointestinal diseases or conditions within 6 months prior to the first dose, including:
History of inflammatory bowel disease;
≥ Grade 2 diarrhea occurring within 2 weeks before the first dose;
Radiation enteritis.
Uncontrolled tumor-related pain or symptomatic hypercalcemia at screening.
Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis.
Patients who are HBsAg-positive and/or hepatitis B core antibody (HBcAb)-positive must have HBV DNA testing. Patients with HBV DNA ≤ 2.5 × 10³ copies/mL or ≤ 500 IU/mL or below the lower limit of detection may be enrolled. HBsAg-positive patients should receive antiviral therapy against HBV throughout study treatment to prevent viral reactivation.
Patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have undetectable HBV viral load do not require prophylactic antiviral treatment but must be closely monitored for HBV reactivation.
Patients with positive HCV serology but negative HCV RNA or HCV RNA below the lower limit of detection may be enrolled.
Patients who have completed HCV treatment and have undetectable viral load may be enrolled.
Severe or uncontrolled infection, infection requiring systemic intravenous antibiotics, or fever of unknown origin > 38°C within 2 weeks prior to the first dose of study drug.
Any other malignancy diagnosed within 5 years before the first dose of study drug, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ that has been completely resected, and localized prostate cancer or papillary thyroid carcinoma that has been cured by radical surgery.
Prohibited medications and treatments (patients must not receive any of the following):
1) IL-2/IL-15-based cytokine therapies. Use of IL-2/IL-15 as a component of adoptive cell therapy or as immune modulation in immunocompromised patients is allowed.
2) Any chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug, without delayed toxicities, with the exception of:
Use of nitrosourea agents or mitomycin C within 6 weeks prior to the first dose is prohibited.
3) Any antibody therapy within 4 weeks prior to the first dose of study drug; 4) Participation in any interventional clinical trial involving medical devices or other therapeutic interventions within 2 weeks prior to the first dose; 5) Palliative radiotherapy within 2 weeks prior to the first dose; 6) Live vaccines for prevention of infectious diseases within 4 weeks prior to the first dose; 7) Immunosuppressive or systemic corticosteroid therapy (> 10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose of study drug; 8) Traditional Chinese medicines with definite antitumor effects within 1 week prior to the first dose.
20. History of significant toxicities related to prior paclitaxel therapy that required permanent discontinuation of that treatment, or any contraindications to study drugs that, in the opinion of the investigator, preclude safe administration of the study treatment.
21. Any disease, treatment, laboratory abnormality, or history of drug abuse which, in the opinion of the investigator, may compromise patient safety, interfere with informed consent, affect patient compliance, or interfere with the evaluation of the safety of the study drug.
22. Psychiatric illness, altered mental status, or history of substance abuse that may interfere with the patient's ability to understand the informed consent process and/or complete required study assessments.
23. Any other condition that, based on known or foreseeable circumstances, in the investigator's judgment would make the patient unable to comply with the protocol requirements.

Trial locations and contacts

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

Yongxu Jia contact

0086-15237128281

fccjiayx@zzu.edu.cn

China1 site

The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yongxu Jia, 0086-15237128281, fccjiayx@zzu.edu.cn

Other trials in China

About this study

Official title: A Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Bevacizumab With or Without Nab-Paclitaxel as Second-Line Therapy in Patients With Advanced Gastric Cancer

The study has two parts. In the phase Ib part, small groups of patients will receive IBI363 plus bevacizumab with or without nab-paclitaxel to evaluate the safety, side effects, and tolerability of the combination and to determine an appropriate dose for further study. In the phase II part, additional patients will receive the selected regimen to assess the preliminary antitumor activity of IBI363 in combination with bevacizumab ± nab-paclitaxel, including tumor response and other clinical outcomes, as well as to further describe the safety profile. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons defined in the protocol.

Conditions: Advan'ce'd, Advanced
Being tested: IBI363, Bevacizumab, Nab-paclitaxel

What participants receive

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

IBI363Drug
IBI363 will be administered as an intravenous infusion at 1.5 mg/kg or 3 mg/kg every 3 weeks (Q3W) in 28-day cycle 1 and 21-day subsequent cycles, in combination with bevacizumab with or without nab-paclitaxel, as second-line therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
BevacizumabBiological
Bevacizumab 7.5 mg/kg will be administered as an intravenous infusion every 3 weeks (Q3W) in combination with IBI363, with or without nab-paclitaxel, and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined reasons.
Nab-paclitaxelDrug
Nab-paclitaxel 260 mg/m² will be administered as an intravenous infusion every 3 weeks (Q3W) for up to 4 cycles in combination with IBI363 and bevacizumab in patients in Cohort 2.

Study groups in NCT07361991
Study group	Role	What they receive
IBI363 + Bevacizumab± nab-paclitaxel	Experimental	Phase Ib Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC or GEJC) who have failed prior standard first-line therapy will receive the following treatments: IBI363 in combination with bevacizumab± nab-paclitaxel. IBI363 will be administered at a dose of 3 mg/kg Q3W in Cycle 1, followed by a maintenance dose of 1.5 mg/kg Q3W. Bevacizumab will be administered at 7.5 mg/kg Q3W. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. Nab-paclitaxel will be administered at 260 mg/m² Q3W for 4 cycles. During the Phase Ib safety lead-in period, patients will be observed for one treatment Receives: Drug: IBI363; Biological: Bevacizumab; Drug: Nab-paclitaxel

What is being measured

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

Incidence and Severity of Adverse Events
Incidence, severity, and relationship to study treatment of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs), graded according to NCI CTCAE. Changes from baseline in 12-lead electrocardiogram (ECG), vital signs, physical examination findings, and clinical laboratory test results will also be assessed.
Measured: From first dose of study treatment until 90 days after the last dose or end of study, whichever occurs first.
Overall Survival (OS)
Overall Survival (OS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of death.
Measured: 12 months after the last subject participating in

Secondary outcomes (5)

Objective Response Rate (ORR) per RECIST v1.1
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Measured: 6 months after the last subject participating in
Disease Control Rate (DCR) per RECIST v1.1
Disease control rate is defined as the proportion of patients with a best overall response of CR, PR, or stable disease (SD) according to RECIST v1.1 as assessed by investigators.
Measured: 12 months after the last subject participating in
Time to Response (TTR)
Time to response is defined as the time from first dose of study treatment to the date of first documented CR or PR according to RECIST v1.1.
Measured: 12 months after the last subject participating in
Duration of Response (DoR)
Duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, according to RECIST v1.1.
Measured: 12 months after the last subject participating in
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from first dose of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: 12 months after the last subject participating in

Timeline

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

Mar 2026Sep 2030

First posted23 Jan 2026
Study startMar 2026 (estimated)
Primary completionSep 2028 (estimated)
Study completionSep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advan'ce'dStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital of Zhengzhou 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07361991
Sponsor's protocol ID: CIBI363GC002
Status last verified: Jan 2026
First submitted: 11 Dec 2025
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Bevacizumab With or Without Nab-Paclitaxel as Second-Line Therapy in Patients With Advanced Gastric Cancer
ClinicalTrials.gov ID: NCT07361991
Acronym / sponsor ID: CIBI363GC002
Conditions: Advan'ce'd, Advanced
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
Study start: Mar 2026 (estimated)
Primary completion: Sep 2028 (estimated)
Study completion: Sep 2030 (estimated)
First posted: 23 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IBI363 + Bevacizumab± nab-paclitaxel	Experimental	Drug: IBI363, Biological: Bevacizumab, Drug: Nab-paclitaxelPhase Ib Patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC or GEJC) who have failed prior standard first-line therapy will receive the following treatments: IBI363 in combination with bevacizumab± nab-paclitaxel. IBI363 will be administered at a dose of 3 mg/kg Q3W in Cycle 1, followed by a maintenance dose of 1.5 mg/kg Q3W. Bevacizumab will be administered at 7.5 mg/kg Q3W. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. Nab-paclitaxel will be administered at 260 mg/m² Q3W for 4 cycles. During the Phase Ib safety lead-in period, patients will be observed for one treatment

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

Signed informed consent: The patient must voluntarily sign a written informed consent form and be able to comply with the visit schedule and procedures specified in the protocol.
Age: 18 to 75 years (inclusive), male or female.
Diagnosis and prior therapy:
1. For patients with PD on immunotherapy: best response during treatment is complete response (CR), partial response (PR), or SD lasting ≥ 12 weeks; 2. For patients who discontinued immunotherapy for reasons other than disease progression and subsequently developed PD: best response during treatment is CR, PR, or SD lasting ≥ 12 weeks, and the interval between last immunotherapy dose and PD is ≤ 6 months.
4. Baseline hematology (within 7 days before first dose of study drug) must meet all of the following:

Key exclusion criteria (45 listed)

Pregnant or breastfeeding women, or women planning to become pregnant before the first dose of study drug, during study treatment, or within 6 months after the last dose.
History of active thrombosis, deep venous thrombosis, or pulmonary embolism within 4 weeks before the first dose of study drug, unless adequately treated and considered clinically stable by the investigator.
Clinically significant cardiovascular or cerebrovascular disease, including but not limited to:
Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, or other forms of restrictive lung disease that require corticosteroids or other treatment, or a history of severely impaired pulmonary function.
History of atopic constitution, asthma, or atopic dermatitis.

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
IBI363IBI363 will be administered as an intravenous infusion at 1.5 mg/kg or 3 mg/kg every 3 weeks (Q3W) in 28-day cycle 1 and 21-day subsequent cycles, in combination with bevacizumab with or without nab-paclitaxel, as second-line therapy for advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.	Drug	IBI363 + Bevacizumab± nab-paclitaxel
BevacizumabBevacizumab 7.5 mg/kg will be administered as an intravenous infusion every 3 weeks (Q3W) in combination with IBI363, with or without nab-paclitaxel, and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined reasons.	Biological	IBI363 + Bevacizumab± nab-paclitaxel
Nab-paclitaxelNab-paclitaxel 260 mg/m² will be administered as an intravenous infusion every 3 weeks (Q3W) for up to 4 cycles in combination with IBI363 and bevacizumab in patients in Cohort 2.	Drug	IBI363 + Bevacizumab± nab-paclitaxel

Primary outcome

Incidence and Severity of Adverse Events
Time frame: From first dose of study treatment until 90 days after the last dose or end of study, whichever occurs first.
Incidence, severity, and relationship to study treatment of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs), graded according to NCI CTCAE. Changes from baseline in 12-lead electrocardiogram (ECG), vital signs, physical examination findings, and clinical laboratory test results will also be assessed.
Overall Survival (OS)
Time frame: 12 months after the last subject participating in
Overall Survival (OS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of death.

5 secondary outcomes

Objective Response Rate (ORR) per RECIST v1.1
Time frame: 6 months after the last subject participating in
Disease Control Rate (DCR) per RECIST v1.1
Time frame: 12 months after the last subject participating in
Time to Response (TTR)
Time frame: 12 months after the last subject participating in
Duration of Response (DoR)
Time frame: 12 months after the last subject participating in
Progression-Free Survival (PFS)
Time frame: 12 months after the last subject participating in

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 23 Jan 2026.
Individual participant dataSharing planned: No

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.

Yongxu Jia contact

0086-15237128281

fccjiayx@zzu.edu.cn

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 IBI363, Bevacizumab and Nab-paclitaxel in people with Advan'ce'd and Advanced, run by The First Affiliated Hospital of Zhengzhou 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 29 inclusion and 45 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 23 Jan 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 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 Yongxu Jia (0086-15237128281, fccjiayx@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Adverse Events (time frame: From first dose of study treatment until 90 days after the last dose or end of study, whichever occurs first.). 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?

On the ClinicalTrials.gov record for NCT07361991.

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 23 Jan 2026.