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Advanced Solid TumorsPhase 1/2NCT07833735

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of SYS6043 ± Bevacizumab ± Chemotherapy in Participants With Advanced Solid Tumors

A Phase 1/2 study testing SYS6043, bevacizumab and carboplatin in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

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 is a multicenter, open-label, safety run-in, dose-expansion and cohort-expansion Phase I/II study designed to evaluate the safety, tolerability, PK profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted ADC) in participants with advanced/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SYS6043, bevacizumab and carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
15 Oct 2026to 15 Oct 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years (inclusive), as of the date of signing the Informed Consent Form (ICF).
  • Phase I Safety Run in Cohort: Participants with solid tumors whose disease has relapsed or progressed during or following standard of care systemic therapy, or who are intolerant to standard of care therapy and for whom no available standard of care treatment exists.
  • Phase II Dose expansion Stage: Participants with solid tumors whose disease has relapsed or progressed during or following standard of care systemic therapy, or who are intolerant to standard of care therapy and for whom no available standard of care treatment exists.
  • Phase II Cohort Expansion Stage: Participants with histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with histological subtypes of high grade serous carcinoma or grade 2 3 endometrioid carcinoma:
  • Cohorts 1/2/3: Platinum sensitive recurrence (platinum sensitive recurrence is defined as disease progression or relapse ≥ 183 days after the last platinum containing chemotherapy).
  • Cohort 1: Participants with platinum sensitive recurrence who achieved clinical complete response (CR) or partial response (PR) following platinum containing chemotherapy combined with bevacizumab. A minimum of 3 cycles of bevacizumab plus platinum based chemotherapy are required. For participants who have undergone interval secondary cytoreductive surgery, administration of only 2 cycles of bevacizumab during the final 3 cycles of second line platinum triplet therapy is permitted. If participants carry germline or somatic BRCA1/2 mutations, prior exposure to PARP inhibitors is required; alternatively, participants may have BRCA wild type or unknown BRCA status. The maximum interval between the last dose of prior triplet therapy (defined as Day 1 of the last cycle of second line platinum containing triplet combination therapy) and Cycle 1 Day 1 (C1D1) of maintenance therapy with bevacizumab or SYS6043 combined with bevacizumab shall be 10 weeks. No clinical evidence of disease progression (by physical examination, imaging, or CA 125) shall be present prior to trial randomization.
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  • Cohort 2: Participants with platinum sensitive recurrence who achieved clinical CR or PR following platinum containing chemotherapy without bevacizumab. If participants carry germline or somatic BRCA1/2 mutations, prior exposure to PARP inhibitors is required; alternatively, participants may have BRCA wild type or unknown BRCA status. The maximum interval between the last dose of prior triplet therapy (defined as Day 1 of the last cycle of second line platinum containing triplet combination therapy) and C1D1 of SYS6043 maintenance therapy shall be 10 weeks. No clinical evidence of disease progression (by physical examination, imaging, or CA 125) shall be present prior to trial randomization.
  • Cohort 3: Participants with platinum sensitive recurrence who have not received prior systemic therapy.
  • Cohort 4: First line treatment setting (no neoadjuvant therapy; newly diagnosed FIGO stage non I disease).
  • Cohort 5: Participants who achieved CR/PR after first line platinum containing chemotherapy with bevacizumab; BRCA1/2 wild type / HRD negative or unknown status. The maximum interval between the last dose of prior triplet therapy (defined as Day 1 of the last cycle of first line platinum containing triplet combination therapy) and C1D1 of maintenance therapy shall be 10 weeks. No clinical evidence of disease progression (by physical examination, imaging, or CA 125) shall be present prior to trial randomization.
  • At least one measurable extracranial target lesion per RECIST Version 1.1 (for Cohort 3 of Phase II only);
  • Participant's expected survival ≥ 3 months;
  • ECOG performance status 0-1 with no deterioration within 28 days prior to enrollment;
  • LVEF ≥ 50% demonstrated by ECHO or MUGA performed within 28 days prior to enrollment;
  • Adequate organ function as defined below, assessed within 7 days prior to enrollment:Major organ function must meet the following criteria within 7 days prior to enrollment:
  • Complete blood count (no whole blood, red blood cell, or platelet transfusion, and no administration of hematopoietic growth factors [G-CSF or GM-CSF], erythropoietin [EPO], or thrombopoietin [TPO] to correct blood cell counts within 7 days before sampling):i. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;Platelet count (PLT) ≥ 100 × 10^9/L;Hemoglobin (HGB) ≥ 90 g/L.
  • Blood biochemistry:i. Serum creatinine ≤ 1.5 × ULN;Serum total bilirubin (TBIL) ≤ 1.5 × ULN (participants with Gilbert's syndrome may be allowed up to 3 × ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN for participants with hepatocellular carcinoma or liver metastasis);Serum albumin ≥ 30 g/L.
  • Coagulation function:
  • Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy; for those on anticoagulation therapy, levels must be within the therapeutic range with stable dose).
  • Any toxicities related to prior therapy have resolved to CTCAE version 6.0 grade ≤1 or baseline level, excluding alopecia, fatigue, pigmentation, hypothyroidism stabilized with hormone replacement therapy, grade 2 peripheral neuropathy following chemotherapy, and other toxicities that the investigator deems not to pose a safety risk to participants.
  • A sufficient washout period from prior anti-tumor therapy is required prior to the first study drug administration.
  • Willing to provide a previously excised tumor sample or undergo a fresh tumor biopsy for the assessment of B7-H3 expression level (if no contraindications exist).
  • Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first administration. Male and female participants with fertility must agree to take adequate contraceptive measures during the study period and for at least 7 months after the last administration of the investigational drug; During this period, women are not breastfeeding, male participants are not allowed to freeze or donate sperm, and female participants are not allowed to donate eggs or retrieve eggs for personal use.
  • Capable and willing to comply with the visits and procedures specified in the protocol.

Who cannot join

  • Participants with non epithelial ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma or sarcoma, mixed tumors containing any of the above histologic subtypes, or low grade / borderline ovarian tumors (Phase II expansion cohort only);
  • Prior exposure to B7 H3 targeted therapy;
  • Prior treatment with topoisomerase 1 inhibitor based antibody drug conjugates (e.g., trastuzumab deruxtecan);
  • History of severe cardiac or cerebrovascular disease, e.g., heart failure with NYHA Class ≥ 2, acute coronary syndrome (e.g., myocardial infarction, unstable angina) within 6 months prior to screening, acute cerebrovascular events (e.g., transient ischemic attack, cerebral infarction, cerebral hemorrhage) within 6 months prior to screening;
  • Mean QT interval corrected by Fredericia formula > 470 ms based on three 12 lead ECG tracings; history of severe arrhythmias (e.g., complete left bundle branch block, third degree atrioventricular block, atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter; transient atrial fibrillation/atrial flutter excluded);
  • Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval;
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  • History of interstitial lung disease / non infectious pneumonitis requiring corticosteroid therapy (e.g., non infectious interstitial pneumonitis, pulmonary interstitial fibrosis, severe radiation pneumonitis), or active interstitial lung disease / non infectious pneumonitis at present, or radiological suspicion of such disease at screening;
  • History of underlying pulmonary disease, including but not limited to pulmonary embolism within 3 months prior to study treatment initiation, severe asthma, severe chronic obstructive pulmonary disease (COPD), severe restrictive lung disease, other clinically significant pulmonary impairment, or requirement for supplemental oxygen;
  • Presence of active pulmonary tuberculosis. Participants who have received adequate anti tuberculosis therapy and completed anti tuberculosis treatment for ≥ 3 months prior to randomization are eligible;
  • Any autoimmune disease, connective tissue disease, or inflammatory disorder with documented or suspected pulmonary involvement at screening (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis);
  • Thrombotic events requiring therapeutic intervention within 6 months prior to screening, including unstable deep vein thrombosis, arterial thrombosis, pulmonary embolism, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. Isolated muscular calf vein thrombosis or catheter related thrombosis may be enrolled if assessed as low risk by the Investigator;
  • Uncontrolled infection requiring intravenous antibacterial, antiviral, or antifungal therapy;
  • Known human immunodeficiency virus (HIV) infection; active syphilis infection (positive treponemal antibody or condition requiring systemic therapy);
  • Participants with active viral hepatitis: positive hepatitis B surface antigen and/or positive hepatitis B core antibody with HBV DNA ≥ 10 000 copies/mL or 2000 IU/mL; positive HCV serology with HCV RNA above the lower limit of quantitation of the assay;
  • Spinal cord compression, clinically active brain metastases, or leptomeningeal metastases. Participants with central nervous system (CNS) metastases are eligible if they have received prior CNS directed therapy and have radiologically and neurologically stable disease for at least 4 weeks before first study drug administration (i.e., no new or progressive metastatic lesions on imaging, no corticosteroid requirement, or stable/decreasing corticosteroid dose equivalent to ≤ 10 mg prednisone per day, and asymptomatic). Untreated asymptomatic CNS metastases are permitted if immediate intervention is not deemed necessary by the Investigator;
  • Active malignancy diagnosed within 3 years prior to randomization, except for radically treated basal cell skin carcinoma, squamous cell skin carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, breast carcinoma in situ, or other radically resected in situ malignancies judged eligible by the Investigator;
  • Moderate or greater pleural, pericardial, or ascitic effusion. Participants may be enrolled if effusion drainage (excluding diagnostic thoracentesis) has been performed and effusion remains stable for at least 2 weeks post drainage;
  • History of female genital tract fistula, genitourinary fistula, enterovaginal fistula, abdominal wall fistula, gastrointestinal perforation, refractory non healed gastric ulcer, or active gastrointestinal bleeding within 6 months prior to enrollment;
  • Bowel obstruction, or signs/symptoms of bowel obstruction, or requirement for parenteral nutrition within 1 month prior to study treatment initiation. Participants may proceed to screening if surgical decompression has been performed with complete resolution of obstruction. Prior enteral stent placement with the stent still in situ at screening;
  • Participants with active bleeding or bleeding diathesis, including known bleeding disorders, coagulopathy, or high bleeding risk tumor involving major blood vessels;
  • Major surgery within 4 weeks prior to screening (biopsy of any type and variceal procedures within 4 weeks are excluded);
  • Unhealed wounds, active ulcers, or fractures. Granulating wounds undergoing secondary intention healing without dehiscence or evidence of infection are permitted; wound assessment shall be performed every 3 weeks;
  • Major traumatic injury within 4 weeks before randomization;
  • Uncontrolled hypertension despite optimal antihypertensive pharmacotherapy, judged by the Investigator to render bevacizumab based therapy inappropriate;
  • History or physical exam evidence of central nervous system disorders, including primary brain tumor, seizures uncontrolled by standard medical therapy, brain metastases, or stroke within 5 years before first study treatment. History of severe psychiatric disorders, including but not limited to dementia, depression, seizure disorder, bipolar affective disorder;
  • Systemic anticoagulation is permitted, with the exception of vitamin K antagonists;
  • Any history of nephrotic syndrome or nephritic syndrome;
  • Clinically significant proteinuria: urine protein to creatinine ratio ≥ 1.0, or urine dipstick protein ≥ 2+, or urinalysis protein ≥ 2+. A 24 hour urine collection must demonstrate ≥ 1 g protein/24 h;
  • Tumor invasion into vital adjacent structures (e.g., mediastinal great vessels, superior vena cava, inferior vena cava, pericardium, heart, trachea, esophagus), or high risk of gastrointestinal / respiratory fistula formation;
  • Current or recent (within 6 months) major gastrointestinal / respiratory disease or condition, including: history of inflammatory bowel disease; post endoprosthesis placement within gastrointestinal or tracheal lumen; Grade ≥ 2 diarrhea within 2 weeks prior to first study drug administration; radiation enteritis;
  • Systemic administration of strong CYP3A4 inhibitors or inducers, or OATP1B1 / OATP1B3 inhibitors within 14 days prior to first study drug dose, or anticipated continued systemic use of such agents during study treatment;
  • Known hypersensitivity to active pharmaceutical ingredient or excipients of study drug;
  • Prior autologous or allogeneic stem cell transplantation;
  • Substance abuse, or any other medical condition that, in the Investigator's opinion, may increase participant safety risk, interfere with study participation, or confound study assessments;
  • Planned live vaccine administration, or receipt of live vaccine within 4 weeks before first study drug dose;
  • Any participant with other severe medical conditions, significant laboratory abnormalities, or poor adherence that may increase risks of study participation or confound study results, and who is deemed unsuitable for this study by the Investigator. Participants with local or systemic non-malignant disorders, or tumor-related sequelae/symptoms associated with substantial medical risk and/or uncertainty in survival assessment, e.g., tumor-related leukemoid reaction (white blood cell count > 20 × 10⁹/L), cachexia.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group officer contact

031169085587

ctr-contact@cspc.cn

About this study

Official title: An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SYS6043 With or Without Bevacizumab, With or Without Chemotherapy in Participants With Advanced Solid Tumors

This is a multicenter, open-label, safety run-in, dose-expansion and cohort-expansion Phase I/II study designed to evaluate the safety, tolerability, PK profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted ADC) in participants with advanced/metastatic solid tumors. The trial consists of two phases: the Phase I component is the safety run-in study, and the Phase II component includes the dose-expansion study and cohort-expansion study.

Being tested
SYS6043, bevacizumab, carboplatin

What participants receive

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

  • SYS6043Drug

    Participants in the experimental group will receive SYS6043, Q3W administered on Day 1 of each cycle..

  • bevacizumabDrug

    Participants in the experimental group will receive bevacizumab Q3W administered on Day 1 of each cycle.

  • carboplatinDrug

    Participants in the experimental group will receive carboplatin Q3W administered on Day 1 of each cycle.

Study groups in NCT07833735
Study groupRoleWhat they receive
SYS6043+ bevacizumabExperimentalIn this group, participants will receive SYS6043 with bevacizumab;
Receives: Drug: SYS6043; Drug: bevacizumab
SYS6043+ carboplatinExperimentalIn this group, participants will receive SYS6043 with carboplatin
Receives: Drug: SYS6043; Drug: carboplatin
SYS6043 + carboplatin + bevacizumabExperimentalIn this froup, participants will receive SYS6043 with carboplatin and bevacizumab
Receives: Drug: SYS6043; Drug: bevacizumab; Drug: carboplatin
SYS6043ExperimentalIn this group, participants will receive SYS6043 ;
Receives: Drug: SYS6043
BevacizumabExperimentalIn this group, participants will receive bevacizumab ;
Receives: Drug: bevacizumab

What is being measured

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

  1. Incidence of dose-limiting toxicities (DLTs) -(Phase I: Safety Run-in Study)

    Measured: 21 days for Arm 1-3.

  2. Incidence of adverse events (AEs) and serious adverse events (SAEs) assessed by CTCAE 6.0-(Phase I: Safety Run-in Study)

    Measured: 2 years

  3. Maximum tolerated dose (MTD) (if any) ) of SYS6043 with or without bevacizumab with or without carboplatin-(Phase I: Safety Run-in Study)

    Measured: Up to 1year

  4. Recommended phase 2 dose (RP2D) of SYS6043 with or without bevacizumab with or without carboplatin-(Phase I: Safety Run-in Study)

    Measured: 2 years

  5. Incidence of adverse events (AEs) and serious adverse events (SAEs) assessed by CTCAE 6.0-(Phase II: Dose-expansion Study)

    Measured: Up to 1year

  6. PFS rate assessed by RECIST Version 1.1(Phase II: Cohort-expansion Study)

    Measured: 2 years

Secondary outcomes (36)

  1. PFS based on RECIST v1.1-(Phase I: Safety Run-in Study)

    Measured: 2 years

  2. ORR based on RECIST v1.1-(Phase I: Safety Run-in Study)

    Measured: 2 years

  3. DoR based on RECIST v1.1-(Phase I: Safety Run-in Study)

    Measured: 2 years

  4. DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1-(Phase I: Safety Run-in Study)

    Measured: 2 years

  5. TTR based on RECIST v1.1-(Phase I: Safety Run-in Study)

    Measured: 2 years

  6. OS-(Phase I: Safety Run-in Study)

    Measured: 2 years

  7. Number of Participants With Anti-Drug Antibodies (ADA): Incidence, titer of anti-SYS6043 antibodies, and incidence of neutralizing antibodies (if applicable) -(Phase I: Safety Run-in Study)

    Measured: 2 years

  8. Serum concentrations of toxin-bound antibody of SYS6043-(Phase I: Safety Run-in Study)

    Measured: 2 years

  9. Serum concentrations of total antibody of SYS6043-(Phase I: Safety Run-in Study)

    Measured: 2 years

  10. Association between B7-H3 expression level and efficacy-(Phase I: Safety Run-in Study)

    Measured: 2 years

  11. Association between B7-H3 expression level and safety-(Phase I: Safety Run-in Study)

    Measured: 2 years

  12. PFS based on RECIST v1.1-(Phase II: Dose expansion Study)

    Measured: 2 years

  13. ORR based on RECIST v1.1-( Phase II: Dose expansion Study)

    Measured: 2 years

  14. DoR based on RECIST v1.1-( Phase II: Dose expansion Study)

    Measured: 2 years

  15. DCR by Blinded Independent Central Review (BICR) based on RECIST v1.1-( Phase II: Dose expansion Study)

    Measured: 2 years

  16. TTR based on RECIST v1.1-( Phase II: Dose expansion Study)

    Measured: 2 years

  17. OS-( Phase II: Dose expansion Study)

    Measured: 2 years

  18. Number of Participants With Anti-Drug Antibodies (ADA): Incidence, titer of anti-SYS6043 antibodies, and incidence of neutralizing antibodies (if applicable) -( Phase II: Dose expansion Study)

    Measured: 2 years

  19. Serum concentrations of toxin-bound antibody of SYS6043-( Phase II: Dose expansion Study)

    Measured: 2 years

  20. Serum concentrations of total antibody of SYS6043-( Phase II: Dose expansion Study)

    Measured: 2 years

  21. Association between B7-H3 expression level and efficacy-( Phase II: Dose expansion Study)

    Measured: 2 years

  22. Association between B7-H3 expression level and safety-( Phase II: Dose expansion Study

    Measured: 2 years

  23. PFS based on RECIST v1.1-(Phase II: Cohort expansion Study)

    Measured: 2 years

  24. ORR based on RECIST v1.1-( Phase II: Cohort expansion Study)

    Measured: 2 years

  25. DoR based on RECIST v1.1-( Phase II: Cohort expansion Study)

    Measured: 2 years

  26. DCR based on RECIST v1.1-( Phase II: Cohort expansion Study)

    Measured: 2 years

  27. TTR based on RECIST v1.1-( Phase II: Cohort expansion Study)

    Measured: 2 years

  28. CA-125 response rate assessed by the investigator-( Phase II: Cohort expansion Study)

    Measured: 2 years

  29. OS-( Phase II: Cohort expansion Study)

    Measured: 2 years

  30. Number of Participants With Anti-Drug Antibodies (ADA): Incidence, titer of anti-SYS6043 antibodies, and incidence of neutralizing antibodies (if applicable) -( Phase II: Cohort expansion Study)

    Measured: 2 years

  31. Serum concentrations of toxin-bound antibody of SYS6043-( Phase II: Cohort expansion Study)

    Measured: 2 years

  32. Serum concentrations of total antibody of SYS6043-( Phase II: Cohort expansion Study)

    Measured: 2 years

  33. Association between B7-H3 expression level and efficacy-(Phase II: Cohort expansion Study)

    Measured: 2 years

  34. Association between B7-H3 expression level and safety-(Phase II: Cohort expansion Study)

    Measured: 2 years

  35. Association between HRR related gene alterations in tumor tissue and efficacy(Phase II: Cohort expansion Study)

    Measured: 2 years

  36. Association between HRR related gene alterations in tumor tissue and safety(Phase II: Cohort expansion Study)

    Measured: 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 posted22 Sep 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion15 Oct 2029 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
multicenter, open-label, safety run-in, dose-expansion and cohort-expansion Phase I/II study
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07833735
Sponsor's protocol ID
SYS6043-003
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYS6043, bevacizumab and carboplatin in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

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 24 inclusion and 36 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) -(Phase I: Safety Run-in Study) (time frame: 21 days for Arm 1-3.). The study lists 6 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 NCT07833735.

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 22 Sep 2026.

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