Pancreatic Adenocarcinoma MetastaticPhase 1NCT07314385
NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer
A Phase 1 study testing nanoliposomal irinotecan+5-FU+leucovorin, NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Aco Apache Ultrasound in people with Pancreatic Adenocarcinoma Metastatic and Liver Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Adenocarcinoma Metastatic, Liver Metastasis
- What is being tested?
- nanoliposomal irinotecan+5-FU+leucovorin, NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Aco Apache Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dated and signed informed consent
- Either sex, aged 18 to 80 years old (inclusive) at the date of consent
- With histologically or cytologically confirmed PDAC
- With life expectancy at least 12 weeks
- Two or more liver metastatic lesions; of them, at least one lesion with the longest diameter (measured on computed tomography [CT] or Magnetic resonance imaging [MRI]) at least 1 cm and not more than 5 cm as well as a depth not more than 7 cm from the skin to the lesion center, and considered feasible for sonoporation by the investigator
- Note: The number of liver metastatic lesions with the longest diameter at least 1 cm should be no more than 10.
Show all 26Show fewer
- Has failed frontline gemcitabine-based chemotherapy and is prepared for an application of NHI-reimbursed nal-IRI, LV, and 5-FU treatment
- Has not received previous radiotherapy, local therapy (e.g., radiofrequency ablation, irreversible electroporation, etc.), or cell therapy (autologous or allogenic) for PDAC
- Has recovered from all treatment-related toxicities or resolved to no greater than grade 1, based on common terminology criteria for adverse events (CTCAE) v.5.0, before enrollment
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- With adequate hematology function at screening, defined as:
- White blood cell (WBC) at least 3,500/mm3
- Absolute neutrophil count (ANC) at least 1,500/mm3
- Hemoglobin at least 10.0 g/dL
- Platelet at least 100,000/mm3
- Prothrombin time (PT) not more than 1.5 fold upper limit of normal (ULN)
- Activated partial thromboplastin time (aPTT) not more than 1.5 fold ULN
- International normalized ratio (INR) of PT not more than 1.5 fold ULN
- With adequate hepatic function at screening, defined as:
- Total bilirubin not more than 2 fold ULN and 2.0 mg/dL
- Alanine transaminase (ALT) and aspartate transaminase (AST) not more than 5 fold ULN and 200 U/L
- With adequate renal function at screening, defined as:
- Serum Creatinine not more than 1.2 mg/dL
- Creatinine clearance at least 50 mL/min (Cockroft-Gault formula)
- Women of childbearing potential, including those experiencing chemical menopause or absence of menstruation for medical reasons, must consent to use at least two contraceptive precautions, one of which must be a condom or other adequate barrier method, and refrain from breastfeeding from informed consent until at least 5 months after the final dose of investigational product.
- Men must consent to use at least one contraceptive precaution from the initiation of the study treatment until at least 3 months after the final dose of the investigational product
Who cannot join
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days before screening
- Presence of diarrhea at least grade 2 based on CTCAE v.5.0
- Concomitant systemic infection requiring treatment
- Clinically significant co-morbid medical conditions, including cardiovascular disease, such as:
- Myocardial infarction within 180 days before screening
- Uncontrollable angina pectoris within 180 days before screening
Show all 24Show fewer
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure at least 150 mmHg or diastolic blood pressure at least 90 mmHg lasting 24 hours or more)
- Arrhythmia requiring treatment
- Prior organ allograft or allogeneic bone marrow transplantation
- Received immunosuppressants within 28 days before screening or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Cycle 1 Day 1
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- Moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment
- Central nervous system metastasis
- Prior or concurrent malignancy other than PDAC within the last 3 years, except for carcinoma in situ of the cervix or basal type skin cancer
- Any major surgery within 4 weeks before screening. Patients must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before Cycle 1 Day 1
- Pregnant women or nursing mothers, or positive pregnancy tests at screening
- Severe mental disorder which may affect the subject s compliance to the study protocol, as judged by the investigator
- Prior history of allergy to agents that is similar to IP such as any MB ultrasound contrast agents or IRI or LV or 5-FU
- Judged by the principal investigator (PI) or sub-investigators to be inappropriate for participation in this study
- Known or suspected hypersensitivity reactions to NH002-related phospholipids or polyethylene glycol (PEG), including prior reactions to common PEG-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)
- Known or suspected hypersensitivity reactions to one or more of the ingredients of NH002, Definity, or other perflutren-containing echocardiographic contrast agent.
- Clinically unstable cardiopulmonary conditions, including but not limited to obstructive lung disease, cardiac shunt abnormalities, or arteriovenous shunt abnormalities, considered not suitable for participation in the trial, in the judgment of the investigator
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Shih-Hung Yang, MD. PhD., +886-72653399, b4401064@gmail.com
About this study
Official title: A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis
This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.
Read the detailed description
With dose escalation under the 3+3 phase I design, NH002-based sonoporation will be performed in 4 cohorts. In cohort 1, NH002 will be given with one short course of sonoporation (on Cycle 1 Day 1). In cohort 2, NH002 will be given with one long course of sonoporation (on Cycle 1 Day 1). In cohort 3, NH002 will be given with two long courses of sonoporation (on Cycle 1 Day 1 and Day 2). In cohort 4, NH002 will be given with three long courses of sonoporation (on Cycle 1 Days 1, 2, and 3). During the NH002-based sonoporation, chemotherapy with standard dose of nanoliposomal irinotecan plus 5-FU and leucovorin will be administered concomitantly. The primary endpoint is safety parameters and to determine the dose-limiting toxicity and maximum tolerated dose.
- Being tested
- nanoliposomal irinotecan+5-FU+leucovorin, NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Aco Apache Ultrasound
- Keywords
- pancreatic adenocarcinoma, liver metastasis, sonoporation, nanoliposomal irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoliposomal irinotecan+5-FU+leucovorinDrug
nanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2
NH002 (Perflutren Lipid Microspheres) Injectable SuspensionDrug
2.5 microliter per kilogram (body weight) per dose
Aco Apache UltrasoundDevice
echo for sonoporation
| Study group | Role | What they receive |
|---|---|---|
| One short sonoporation | Experimental | one short course of sonoporation (on Cycle 1 Day 1)
* NH002: 1 dose
* sonoporation: 1 course (10 min) Receives: Drug: nanoliposomal irinotecan+5-FU+leucovorin; Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension; Device: Aco Apache Ultrasound |
| One long sonoporation | Experimental | one long course of sonoporation (Cycle 1, Day 1)
* NH002: 2 doses
* sonoporation: 2 courses (20 min) Receives: Drug: nanoliposomal irinotecan+5-FU+leucovorin; Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension; Device: Aco Apache Ultrasound |
| two long sonoporation | Experimental | two long courses of sonoporation (Cycle 1, Day 1 \& 2)
* NH002: 2 doses, D1 \& D2
* sonoporation: 2 courses (20 min), D1 \& D2 Receives: Drug: nanoliposomal irinotecan+5-FU+leucovorin; Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension; Device: Aco Apache Ultrasound |
| three long sonoporation | Experimental | three long courses of sonoporation (Cycle 1, Day 1, 2 \& 3)
* NH002: 2 doses; D1, D2 \& D3
* sonoporation: 2 courses (20 min); D1, D2 \& D3 Receives: Drug: nanoliposomal irinotecan+5-FU+leucovorin; Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension; Device: Aco Apache Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: within 28 days (Cycle 1)
MTD
To determine the maximum tolerated dose of NH002 in the 3+3 design according to assessment of dose-limiting toxicities with CTCAE v 5.0
Measured: within 28 days (cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma MetastaticStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Trust Bio-sonics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314385
- Sponsor's protocol ID
- 202410052MIPA
- Other IDs
- TBS-602-S01
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han F, Wang Y, Dong X, Lin Q, Wang Y, Gao W, Yun M, Li Y, Gao S, Huang H, Li N, Luo T, Luo X, Qiu M, Zhang D, Yan K, Li A, Liu Z. Clinical sonochemotherapy of inoperable pancreatic cancer using diagnostic ultrasound and microbubbles: a multicentre, open-label, randomised, controlled trial. Eur Radiol. 2024 Mar;34(3):1481-1492. doi: 10.1007/s00330-023-10210-4. Epub 2023 Oct 5.
PubMed 37796294Dimcevski G, Kotopoulis S, Bjanes T, Hoem D, Schjott J, Gjertsen BT, Biermann M, Molven A, Sorbye H, McCormack E, Postema M, Gilja OH. A human clinical trial using ultrasound and microbubbles to enhance gemcitabine treatment of inoperable pancreatic cancer. J Control Release. 2016 Dec 10;243:172-181. doi: 10.1016/j.jconrel.2016.10.007. Epub 2016 Oct 12.
PubMed 27744037Lin CY, Li JR, Tseng HC, Wu MF, Lin WL. Enhancement of focused ultrasound with microbubbles on the treatments of anticancer nanodrug in mouse tumors. Nanomedicine. 2012 Aug;8(6):900-7. doi: 10.1016/j.nano.2011.10.005. Epub 2011 Oct 25.
PubMed 22033084Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
PubMed 26615328
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis
- ClinicalTrials.gov ID
- NCT07314385
- Acronym / sponsor ID
- 202410052MIPA
- Keywords
- pancreatic adenocarcinoma, liver metastasis, sonoporation, nanoliposomal irinotecan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Trust Bio-sonics, Inc.
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 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.
This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.
Detailed description
With dose escalation under the 3+3 phase I design, NH002-based sonoporation will be performed in 4 cohorts. In cohort 1, NH002 will be given with one short course of sonoporation (on Cycle 1 Day 1). In cohort 2, NH002 will be given with one long course of sonoporation (on Cycle 1 Day 1). In cohort 3, NH002 will be given with two long courses of sonoporation (on Cycle 1 Day 1 and Day 2). In cohort 4, NH002 will be given with three long courses of sonoporation (on Cycle 1 Days 1, 2, and 3). During the NH002-based sonoporation, chemotherapy with standard dose of nanoliposomal irinotecan plus 5-FU and leucovorin will be administered concomitantly. The primary endpoint is safety parameters and to determine the dose-limiting toxicity and maximum tolerated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3+3
| Arm | Type | Receives |
|---|---|---|
| One short sonoporation | Experimental | Drug: nanoliposomal irinotecan+5-FU+leucovorin, Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Device: Aco Apache Ultrasoundone short course of sonoporation (on Cycle 1 Day 1) * NH002: 1 dose * sonoporation: 1 course (10 min) |
| One long sonoporation | Experimental | Drug: nanoliposomal irinotecan+5-FU+leucovorin, Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Device: Aco Apache Ultrasoundone long course of sonoporation (Cycle 1, Day 1) * NH002: 2 doses * sonoporation: 2 courses (20 min) |
| two long sonoporation | Experimental | Drug: nanoliposomal irinotecan+5-FU+leucovorin, Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Device: Aco Apache Ultrasoundtwo long courses of sonoporation (Cycle 1, Day 1 \& 2) * NH002: 2 doses, D1 \& D2 * sonoporation: 2 courses (20 min), D1 \& D2 |
| three long sonoporation | Experimental | Drug: nanoliposomal irinotecan+5-FU+leucovorin, Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension, Device: Aco Apache Ultrasoundthree long courses of sonoporation (Cycle 1, Day 1, 2 \& 3) * NH002: 2 doses; D1, D2 \& D3 * sonoporation: 2 courses (20 min); D1, D2 \& D3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Dated and signed informed consent
- Either sex, aged 18 to 80 years old (inclusive) at the date of consent
- With histologically or cytologically confirmed PDAC
- With life expectancy at least 12 weeks
- Two or more liver metastatic lesions; of them, at least one lesion with the longest diameter (measured on computed tomography [CT] or Magnetic resonance imaging [MRI]) at least 1 cm and not more than 5 cm as well as a depth not more than 7 cm from the skin to the lesion center, and considered feasible for sonoporation by the investigator
Key exclusion criteria (24 listed)
- Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days before screening
- Presence of diarrhea at least grade 2 based on CTCAE v.5.0
- Concomitant systemic infection requiring treatment
- Clinically significant co-morbid medical conditions, including cardiovascular disease, such as:
- Prior organ allograft or allogeneic bone marrow transplantation
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 |
|---|---|---|
| nanoliposomal irinotecan+5-FU+leucovorinnanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2 | Drug | One long sonoporation, One short sonoporation, three long sonoporation, two long sonoporation |
| NH002 (Perflutren Lipid Microspheres) Injectable Suspension2.5 microliter per kilogram (body weight) per dose | Drug | One long sonoporation, One short sonoporation, three long sonoporation, two long sonoporation |
| Aco Apache Ultrasoundecho for sonoporation | Device | One long sonoporation, One short sonoporation, three long sonoporation, two long sonoporation |
Primary outcome
AE
Time frame: within 28 days (Cycle 1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
MTD
Time frame: within 28 days (cycle 1)
To determine the maximum tolerated dose of NH002 in the 3+3 design according to assessment of dose-limiting toxicities with CTCAE v 5.0
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 Jan 2026.
- Background: PubMed 37796294Han F, Wang Y, Dong X, Lin Q, Wang Y, Gao W, Yun M, Li Y, Gao S, Huang H, Li N, Luo T, Luo X, Qiu M, Zhang D, Yan K, Li A, Liu Z. Clinical sonochemotherapy of inoperable pancreatic cancer using diagnostic ultrasound and microbubbles: a multicentre, open-label, randomised, controlled trial. Eur Radiol. 2024 Mar;34(3):1481-1492. doi: 10.1007/s00330-023-10210-4. Epub 2023 Oct 5.
- Background: PubMed 27744037Dimcevski G, Kotopoulis S, Bjanes T, Hoem D, Schjott J, Gjertsen BT, Biermann M, Molven A, Sorbye H, McCormack E, Postema M, Gilja OH. A human clinical trial using ultrasound and microbubbles to enhance gemcitabine treatment of inoperable pancreatic cancer. J Control Release. 2016 Dec 10;243:172-181. doi: 10.1016/j.jconrel.2016.10.007. Epub 2016 Oct 12.
- Background: PubMed 22033084Lin CY, Li JR, Tseng HC, Wu MF, Lin WL. Enhancement of focused ultrasound with microbubbles on the treatments of anticancer nanodrug in mouse tumors. Nanomedicine. 2012 Aug;8(6):900-7. doi: 10.1016/j.nano.2011.10.005. Epub 2011 Oct 25.
- Background: PubMed 26615328Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
- Individual participant dataSharing planned: No
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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 1 study testing nanoliposomal irinotecan+5-FU+leucovorin, NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Aco Apache Ultrasound in people with Pancreatic Adenocarcinoma Metastatic and Liver Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 26 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: opening soon, as of the sponsor's last update on 2 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 Taiwan. 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 Shih-Hung Yang, MD. PhD. (+886-72653399, b4401064@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (time frame: within 28 days (Cycle 1)). 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 NCT07314385, which also lists 4 linked publications.
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 Jan 2026.