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Metastatic Clear Cell Renal Cell CarcinomaPhase 2NCT07578025

Zanzalintinib and MO-03 for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

A Phase 2 study testing Biospecimen Collection, Bone Scan and C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03 in people with Metastatic Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.

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 phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progression) after receiving immunotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Scan and C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
28 Nov 2026to 24 Jun 2028
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

  • Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
  • Agreement to allow the use of archival tissue from diagnostic tumor biopsies
  • If unavailable, exceptions may be granted with study principal investigator (PI) approval
  • Age: ≥ 18 years
  • Gender: Males and females are eligible
  • Any ethnicity or race
Show all 34Show fewer
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Histologically confirmed renal cell carcinoma with a clear-cell histology
  • Patients must have received one or two prior lines of systemic therapy for metastatic disease, which must include prior treatment with a checkpoint inhibitor and cabozantinib (not necessarily in the same line). Prior use of hypoxia-inducible factor (HIF) inhibitors or other tyrosine kinase inhibitors (TKIs) other than cabozantinib are not allowed
  • Measurable metastatic disease by RECIST v 1.1 criteria
  • Recovery to baseline or ≤ grade 1 severity (CTCAE v 6.0) from adverse events (AEs), including immune-related adverse events (irAEs), related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alopecia, ≤ grade 2 hypomagnesemia, ≤ grade 2 neuropathy are permitted)
  • White blood cell (WBC) > 2,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Growth factor is not permitted within 14 days of absolute neutrophil count (ANC) assessment unless cytopenia is secondary to disease involvement
  • Neutrophils ≥ 1,500/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Growth factor is not permitted within 14 days of absolute neutrophil count (ANC) assessment unless cytopenia is secondary to disease involvement
  • Platelets ≥ 100,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
  • Hemoglobin ≥ 9g/dL (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement
  • Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (except for subjects with Gilbert Syndrome, who may have total bilirubin up to 3.0 mg/dL) (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Aspartate aminotransferase (AST) ≤ 3.0 x ULN (except for subjects with Gilbert Syndrome, who may have total bilirubin up to 3.0 mg/dL) (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Alkaline phosphatase (ALP) ≤ 3.0 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • Creatinine clearance ≥ 40 mL/min the Cockcroft-Gault formula (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN. If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.2 x ULN, INR ≤ 1.5. If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (to be performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)
  • QT interval corrected by Bazett's formula (QTcB) ≤ 480 ms
  • Note: To be performed within 28 days prior to day 1 of protocol therapy
  • If seropositive for HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected, chronic carriers of HBV, and chronic carriers of HCV on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Meets other institutional and federal requirements for infectious disease titer requirements
  • Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Sexually active fertile subjects and their partners must agree to use highly effective method of contraception during the course of the study and for the following durations after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods, through 186 days after the last dose of zanzalintinib for women of childbearing potential (WOCBP) or through 96 days after the last dose of zanzalintinib for men
  • Female subjects of childbearing potential must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met: permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman > 45 years-of-age in the absence of other biological or physiological causes. In addition, females < 55 years-of-age must have a serum follicle stimulating hormone [FSH] level > 40 mIU/mL to confirm menopause).
  • Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff

Who cannot join

  • Prior treatment with zanzalintinib
  • Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment
  • Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.
  • Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed
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  • Known medical condition (e.g., chronic diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
  • Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin inhibitors ) and platelet inhibitors (e.g., clopidogrel).Allowed anticoagulants are the following:
  • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
  • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
  • Note: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer
  • Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment
  • The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Unstable or deteriorating cardiovascular disorders:
  • Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).
  • Uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other clinically significant arterial thrombotic and/or ischemic event within 6 months before first dose of study treatment.
  • Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment.
  • Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen.
  • Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator
  • Prior history of myocarditis.
  • Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
  • Tumors invading the GI-tract from external viscera.
  • Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis.
  • Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic.
  • Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.
  • Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment
  • Known gastric or esophageal varices
  • Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks
  • Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment
  • Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed)
  • Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
  • Note: Subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval
  • Other clinically significant disorders that would preclude safe study participation
  • Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.
  • Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for subjects meeting all of the following criteria:
  • (1) Chronic carriers of HBV infection (hepatitis B surface antigen [HBsAg]-positive, anti-hepatitis B core antibody [anti-HBc]-positive) who have undetectable HBV deoxyribonucleic acid (DNA) and are on stable suppressive antiviral therapy.
  • (2) Individuals with prior HCV infection who have completed curative antiviral treatment and achieved undetectable HCV viral load.
  • (3) Chronic carriers of HCV infection who are on stable suppressive antiviral therapy and have undetectable HCV viral load.
  • (4) HIV-infected patients on stable anti-retroviral therapy with CD4+ T cell count ≥ 200/µL; and) an undetectable viral load. *** Note: HIV testing will be performed at screening if and as required by local regulation.
  • Note: To be eligible, participants taking CYP inhibitors (e.g., zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.
  • Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.
  • Serious non-healing wound/ulcer/bone fracture.
  • Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.
  • Malabsorption syndrome.
  • Pharmacologically uncompensated, symptomatic hypothyroidism.
  • Moderate to severe hepatic impairment (Child-Pugh B or C).
  • Requirement for hemodialysis or peritoneal dialysis.
  • History of solid organ or allogeneic stem cell transplant
  • Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (i.e. nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment
  • Note: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.
  • Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility
  • History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
  • Women who are pregnant or breastfeeding
  • Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations
  • Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6
  • Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

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

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

    Sumanta K. Pal, 626-256-4673, spal@coh.org

    Sumanta K. Pal

Other trials in United States

About this study

Official title: Phase 2, Single-Arm Trial of Zanzalintinib (XL092) With MO-03 (CBM588 Capsule) in Patients With Metastatic Renal Cell Carcinoma (mRCC) After Progression to Immunotherapy

This phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progression) after receiving immunotherapy. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. MO-03 is a type of medication called a microbiome-based immunomodulator. It helps control some of the bacteria found in the gut which may make the zanzalintinib more effective. Giving zanzalintinib with MO-03 may be effective for treating metastatic renal cell cancer after progression on immunotherapy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the anti-tumor efficacy of zanzalintinib (XL092) in combination with C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03 (MO-03) in patients with metastatic renal cell carcinoma (mRCC) at second line or third line after disease progression to both a checkpoint inhibitor and cabozantinib, as measured by the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria.

SECONDARY OBJECTIVES:

  1. To assess changes in the gut microbiome composition from baseline to week 12, to understand the impact of CBM588 with XL092 on microbiome modulation.

II. To evaluate microbial diversity changes by comparing the Shannon index from baseline to week 12 with MO-03 and XL092, to explore any association between microbial diversity and treatment response.

III. To examine immune modulation, specifically by measuring changes in the proportion of circulating regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs) with the combination of XL092 and MO-03.

IV. To assess cytokine and chemokine levels at various points during the study to evaluate the immunologic response associated with XL092 and MO-03.

  1. To evaluate the safety and tolerability of the XL092 and MO-03 combination, focusing on treatment-related toxicities such as diarrhea and nausea, and analyzing all adverse events and serious adverse events per Common Terminology Criteria for Adverse Events (CTCAE) v 6.0.

VI. To analyze survival outcomes, specifically progression-free survival (PFS) and overall survival (OS), using Kaplan-Meier estimates to determine time-to-event distributions and provide an early indication of clinical benefit.

EXPLORATORY OBJECTIVES:

  1. To assess the changes in metabolic pathways within the gut microbiome over the course of treatment with XL092 and MO-03.

II. To evaluate the changes in fungal microbiome profiles in response to treatment with XL092 and MO-03.

OUTLINE:

Patients receive XL092 orally (PO) once daily (QD) and MO-03 PO twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Study treatment may continue after progression if the Investigator believes that the subject is still receiving clinical benefit. Patients undergo computed tomography (CT) scan, bone scan, and blood and urine sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days and every 12 weeks for 2 years.

Being tested
Biospecimen Collection, Bone Scan, C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03, Computed Tomography, Zanzalintinib
Medical subject headings
Clear-cell metastatic renal cell carcinoma, Carcinoma, Renal Cell

What participants receive

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

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and urine sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03Drug

    Also called CBM588 Capsule Formulation MO-03, CBM588 Capsule MO-03, Clostridium butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03, Clostridium butyricum CBM 588 Probiotic Strain Capule MO-03

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • ZanzalintinibDrug

    Also called Multi-kinase Inhibitor XL092, XL 092, XL-092, XL092

    Given PO

Study groups in NCT07578025
Study groupRoleWhat they receive
Treatment (zanzalintinib and MO-03)ExperimentalPatients receive XL092 PO QD and MO-03 PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Study treatment may continue after progression if the Investigator believes that the subject is still receiving clinical benefit. Patients undergo CT scan, bone scan, and blood and urine sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03; Procedure: Computed Tomography; Drug: Zanzalintinib

What is being measured

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

  1. Overall response rate

    Will be calculated as the number of patients with complete or partial response (per Response Evaluation Criteria in Solid Tumors version 1.1) divided by the total number of treated/evaluable subjects.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Change in gut microbiota composition in stool

    Assessed using the proportion of Bifidobacterium spp.

    Measured: From baseline to week 12

  2. Microbial diversity

    Assessed via comparison of the Shannon index.

    Measured: From baseline to week 12

  3. Proportion of circulating regulatory T cells

    Will be assessed graphically across serial timepoints of blood collection to ascertain any trends.

    Measured: At baseline, week 9, 13, 17 and 25

  4. Proportion of circulating myeloid-derived suppressor cells

    Will be assessed graphically across serial timepoints of blood collection to ascertain any trends.

    Measured: At baseline, week 9, 13, 17 and 25

  5. Cytokine levels

    Will be assessed graphically across serial timepoints of blood collection to ascertain any trends.

    Measured: At baseline, week 9, 13, 17 and 25

  6. Chemokine levels

    Will be assessed graphically across serial timepoints of blood collection to ascertain any trends.

    Measured: At baseline, week 9, 13, 17 and 25

  7. Treatment related toxicities

    Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0.

    Measured: From baseline, up to 2 years

  8. Incidence of adverse events

    Assessed using CTCAE v 6.0.

    Measured: Up to 2 years

  9. Incidence of serious adverse events

    Assessed using CTCAE v 6.0.

    Measured: Up to 2 years

  10. Progression free survival

    Estimated using the Kaplan-Meier method with 80% confidence bands.

    Measured: From start of treatment to time of progression or death, up to 2 years

  11. Overall survival

    Estimated using the Kaplan-Meier method with 80% confidence bands.

    Measured: From start of treatment to death from any cause, 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.

  1. First posted11 May 2026
  2. Study start28 Nov 2026 (estimated)
  3. Primary completion24 Jun 2028 (estimated)
  4. Study completion24 Jun 2028 (estimated)

Resources

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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07578025
Sponsor's protocol ID
24926
Other IDs
NCI-2026-02916, 24926, P30CA033572
Status last verified
May 2026
First submitted
5 May 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Scan and C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03 in people with Metastatic Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by City of Hope 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 34 inclusion and 60 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 11 May 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Up to 2 years). 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 NCT07578025.

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 11 May 2026.

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