Hepatobiliary CancerPhase 2NCT05724563
Domvanalimab and Zimberelimab in Advanced Liver Cancers
A Phase 2 study testing Zimberelimab and Domvanalimab in people with Hepatobiliary Cancer and Liver Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about advanced liver and bile duct cancers. The main question it aims to answer is: If the combination of Domvanalimab and Zimberelimab are effective in treating advanced hepatobiliary cancers that have failed prior treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatobiliary Cancer, Liver Cancer, Cholangiocarcinoma
- What is being tested?
- Zimberelimab and Domvanalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have a histologically confirmed diagnosis consistent with HCC or bile duct cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers); known fibrolamellar HCC, or combined HCC-cholangiocarcinoma will be excluded.
- Locally advanced or metastatic disease
- 2a. Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
- 2b. Measurable disease, as defined as lesions that can accurately be measured in at east one dimension according to RECIST version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography).
- Refractory to or relapsed after prior anti-PD-1/L1 antibody therapy. May have received anti-PD-1/L1 monotherapy or combination therapy as any line of therapy including in the neoadjuvant or adjuvant setting. Patients who discontinued prior immune checkpoint inhibitor treatment due to toxicity are not eligible.
- Availability of recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or slides in which the biopsy or resection was performed within 3 years. Baseline tissue can be obtained after consent but must be prior to initiation of zimberelimab and domvanalimab. It is strongly recommended that tissue is obtained from biopsies confirming progression of disease on prior therapy so that the patient has not received any intervening systemic anti-cancer treatment from the time that the baseline tissue was obtained.
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- Prior locoregional is allowed provided the following are met: 1) at least 2 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation; 2) target lesion has increased in size ≥25% or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion and radiotherapy will be completed at least 2 weeks prior to study drug administration.
- Age ≥ 18 years
- Child-Pugh Score A or B7-8 (only for Cohort A)
- ECOG Performance score of 0-1
- Adequate organ and marrow function (without chronic, ongoing growth factor support or transfusion in the last 2 weeks) as defined below:
- 9a. Platelet count ≥ 50,000/mm^3
- 9b. Hgb ≥ 8.5 g/dl
- 9c. Absolute neutrophil ≥ 1,000 cells/mm^3
- 9d. Total bilirubin ≤ 3.0 mg/ml (This will not apply to subjects with Gilbert's syndrome who have persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis, and such patients may be enrolled based in consultation with the principal investigator).
- 9e. INR ≤ 2
- 9f. AST, ALT ≤5 times ULN
- 9g. Calculated creatinine clearance (CrCl) ≥ 40 mL/min. CrCl can be calculated using the Cockroft-Gault method.
- 9h. Albumin ≥ 2.0 g/dl
- All men, as well as women of child-bearing potential, defined as not surgically sterilized and between menarche and 1-year post menopause, must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 4 weeks prior to study entry, for the duration of study participation, and for 120 days after the last dose of zimberelimab or domvanalimab. See contraception guidelines in Appendix 1. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Women of child-bearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication
- Subjects are eligible to enroll if they have non-viral-HCC, or if they have HBV-HCC, or HCV-HCC defined as follows:
- 1. HBV-HCC: Hepatitis B subjects will be allowed if they meet the following criteria: On antiviral therapy for HBV or HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Subjects on active HBV therapy with viral loads under 100 IU/ml should stay on the same therapy throughout study treatment. Subjects who are anti-HBc (+), negative for HBsAg, negative for anti-HBs, and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis.
- 2. HCV-HCC: Active or resolved HCV infection as evidenced by detectable HCV RNA or antibody. Patients who have failed HCV therapy as evidenced by detectable HCV RNA will be eligible. Subjects with chronic infection by HCV who are treated (successfully or treatment failure) or untreated are allowed on study. In addition, subjects with successful HCV treatment are allowed as long as there are ≥4 weeks between completion of HCV therapy and start of study drug. Successful HCV treatment definition: SVR12.
- Ability to understand and the willingness to sign a written informed consent.
- Willing and able to comply with the requirements and restrictions in this protocol.
- Patients who have received the vector, protein subunit, or nucleic acid COVID-19 vaccines are eligible to enroll.
Who cannot join
- Prior liver transplant.
- Known human immunodeficiency virus (HIV) positive (testing not required).
- Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.
- History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure).
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:
- 5a. Interstitial lung disease, including history of interstitial lung disease or non infectious pneumonitis (lymphangitic spread of cancer is not disqualifying),
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- 5b. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of the initiation of study drugs,
- 5c. Clinically significant cardiovascular disease,
- 5d. A condition that may obscure the interpretation of toxicity determination or AEs,
- 5e. History of prior solid-organ transplantation.
- Hypersensitivity to IV contrast; not suitable for pre-medication.
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
- 8a. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- 8b. Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study. Participants on chronic systemic corticosteroids will be excluded from the study.
- Known history of active bacillus tuberculosis.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of study administration. Inhaled or topical steroids and adrenal replacement doses ≤10 mg/day prednisone equivalents are permitted in the absence of autoimmune disease.
- Known severe hypersensitivity reactions to monoclonal antibodies (≥Grade 3).
- Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.
- Prisoners or subjects who are involuntarily incarcerated.
- If a participant has symptomatic or clinically active brain metastases including leptomeningeal disease, they must be excluded if:
- Has evidence of progression by neurologic symptoms
- Has metastatic brain lesions that require immediate intervention.
- Has carcinomatous meningitis, regardless of clinical stability
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has significant dementia or other mental condition that precludes the participant's ability to consent to the study.
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drugs.
- Known hypersensitivity to recombinant proteins, or any excipient contained in the study drug formulations.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
About this study
Official title: Phase II Basket Trial of Domvanalimab (AB154) and Zimberelimab (AB122) in Advanced Hepatobiliary Cancers
The goal of this clinical trial is to learn about advanced liver and bile duct cancers. The main question it aims to answer is:
If the combination of Domvanalimab and Zimberelimab are effective in treating advanced hepatobiliary cancers that have failed prior treatment.
- Being tested
- Zimberelimab, Domvanalimab
- Medical subject headings
- Liver Neoplasms, Cholangiocarcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZimberelimabDrug
Also called AB122
Zimberelimab 360 mg IV every 3 weeks until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
DomvanalimabDrug
Also called AB154
Domvanalimab 1200 mg IV every 3 weeks until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason.
| Study group | Role | What they receive |
|---|---|---|
| Zimberelimab and Domvanalimab | Experimental | Individual will be given Zimberelimab (AB122) 360 mg IV in a 1 hour infusion + 30 minute rest + Domvanalimab (AB154) 1200 mg IV in a 1 hour infusion every three weeks. Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason Receives: Drug: Zimberelimab; Drug: Domvanalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response rate of combination zimberelimab and domvanalimab.
To determine the best objective response rate assessed by RECIST guidelines (version 1.1) of combination zimberelimab and domvanalimab in patients with advanced hepatobiliary cancers previously exposed to anti-PD-1/L1 antibody treatments.
Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Secondary outcomes (5)
Disease Control Rate of combination zimberelimab and domvanalimab
To determine the disease control rate of response of combination zimberelimab and domvanalimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Overall survival of combination zimberelimab and domvanalimab
To determine the overall survial rate of response of combination zimberelimab and domvanalimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
6-month progression-free survival of combination zimberelimab and domvanalimab
To determine the 6 month progression-free survival rate of response of combination zimberelimab and domvanalimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Duration of response of combination zimberelimab and domvanalimab
To determine the duration of response of combination zimberelimab and domvanalimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Number of participants with Adverse Events (AEs) (serious / non-serious) as defined by CTCAE v5.0
Safety profile of combination zimberelimab and domvanalimab will be measured by the number of participants with Adverse Events (AEs) (serious / non-serious) as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start12 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatobiliary CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arcus Biosciences, Inc., Cancer Prevention Research Institute of Texas
- Responsible party
- Principal investigator, David Hsieh, University of Texas Southwestern Medical Center
- Investigators
- David Hsieh, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724563
- Sponsor's protocol ID
- SCCC-20Y22; STU-2022-1076
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsiehchen D, Lohrey JH, Kainthla R, Kazmi SMA, Verma N, Manwaring C, Ahn C, Zhu H. Domvanalimab plus zimberelimab in unresectable and immunotherapy refractory biliary tract cancers: a phase 2 trial. Nat Commun. 2026 Jul 21;17(1):8886. doi: 10.1038/s41467-026-75554-z.
PubMed 42481461Hsiehchen D, Kainthla R, Kline H, Siglinsky E, Ahn C, Zhu H. Dual TIGIT and PD-1 blockade with domvanalimab plus zimberelimab in hepatocellular carcinoma refractory to anti-PD-1 therapies: the phase 2 LIVERTI trial. Nat Commun. 2025 Jul 1;16(1):5819. doi: 10.1038/s41467-025-60757-7.
PubMed 40592848
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Basket Trial of Domvanalimab (AB154) and Zimberelimab (AB122) in Advanced Hepatobiliary Cancers
- ClinicalTrials.gov ID
- NCT05724563
- Acronym / sponsor ID
- SCCC-20Y22; STU-2022-1076
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Arcus Biosciences, Inc., Cancer Prevention Research Institute of Texas
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Feb 2023 (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.
The goal of this clinical trial is to learn about advanced liver and bile duct cancers. The main question it aims to answer is:
If the combination of Domvanalimab and Zimberelimab are effective in treating advanced hepatobiliary cancers that have failed prior treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zimberelimab and Domvanalimab | Experimental | Drug: Zimberelimab, Drug: DomvanalimabIndividual will be given Zimberelimab (AB122) 360 mg IV in a 1 hour infusion + 30 minute rest + Domvanalimab (AB154) 1200 mg IV in a 1 hour infusion every three weeks. Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patient must have a histologically confirmed diagnosis consistent with HCC or bile duct cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers); known fibrolamellar HCC, or combined HCC-cholangiocarcinoma will be excluded.
- Locally advanced or metastatic disease
- Refractory to or relapsed after prior anti-PD-1/L1 antibody therapy. May have received anti-PD-1/L1 monotherapy or combination therapy as any line of therapy including in the neoadjuvant or adjuvant setting. Patients who discontinued prior immune checkpoint inhibitor treatment due to toxicity are not eligible.
- Availability of recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or slides in which the biopsy or resection was performed within 3 years. Baseline tissue can be obtained after consent but must be prior to initiation of zimberelimab and domvanalimab. It is strongly recommended that tissue is obtained from biopsies confirming progression of disease on prior therapy so that the patient has not received any intervening systemic anti-cancer treatment from the time that the baseline tissue was obtained.
- Prior locoregional is allowed provided the following are met: 1) at least 2 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation; 2) target lesion has increased in size ≥25% or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion and radiotherapy will be completed at least 2 weeks prior to study drug administration.
Key exclusion criteria (29 listed)
- Prior liver transplant.
- Known human immunodeficiency virus (HIV) positive (testing not required).
- Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.
- History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure).
- Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:
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 |
|---|---|---|
| ZimberelimabAlso: AB122Zimberelimab 360 mg IV every 3 weeks until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. | Drug | Zimberelimab and Domvanalimab |
| DomvanalimabAlso: AB154Domvanalimab 1200 mg IV every 3 weeks until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. | Drug | Zimberelimab and Domvanalimab |
Primary outcome
Objective Response rate of combination zimberelimab and domvanalimab.
Time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
To determine the best objective response rate assessed by RECIST guidelines (version 1.1) of combination zimberelimab and domvanalimab in patients with advanced hepatobiliary cancers previously exposed to anti-PD-1/L1 antibody treatments.
5 secondary outcomes
Disease Control Rate of combination zimberelimab and domvanalimab
Time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Overall survival of combination zimberelimab and domvanalimab
Time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
6-month progression-free survival of combination zimberelimab and domvanalimab
Time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Duration of response of combination zimberelimab and domvanalimab
Time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Number of participants with Adverse Events (AEs) (serious / non-serious) as defined by CTCAE v5.0
Time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 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 Jul 2026.
- Derived from this study: PubMed 42481461Hsiehchen D, Lohrey JH, Kainthla R, Kazmi SMA, Verma N, Manwaring C, Ahn C, Zhu H. Domvanalimab plus zimberelimab in unresectable and immunotherapy refractory biliary tract cancers: a phase 2 trial. Nat Commun. 2026 Jul 21;17(1):8886. doi: 10.1038/s41467-026-75554-z.
- Derived from this study: PubMed 40592848Hsiehchen D, Kainthla R, Kline H, Siglinsky E, Ahn C, Zhu H. Dual TIGIT and PD-1 blockade with domvanalimab plus zimberelimab in hepatocellular carcinoma refractory to anti-PD-1 therapies: the phase 2 LIVERTI trial. Nat Commun. 2025 Jul 1;16(1):5819. doi: 10.1038/s41467-025-60757-7.
- 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. This study is not recruiting at the moment.
David Hsieh, MD principal investigator
Assistant Professor
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 Zimberelimab and Domvanalimab in people with Hepatobiliary Cancer and Liver Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response rate of combination zimberelimab and domvanalimab. (time frame: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months). 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 NCT05724563, which also lists 2 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 Jul 2026.