Nasopharyngeal Carcinoma (NPC)Phase 2NCT07388758
Scipibaimab Combined With Tislelizumab in Patients With First-Line Treatment-Failed Recurrent/Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Tislelizumab and Scipibaimab in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Tislelizumab and Scipibaimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Feb 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy.
- 2. Age ≥ 18 years and ≤ 75 years, both genders.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- 4. Life expectancy of at least 3 months.
- 5. Have failed for first-line platinum-based chemotherapy.
- 6. Have failed for prior treatment with PD-1 antagonists +/- chemotherapy.
Show all 10Show fewer
- 7. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
- 8. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN ; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN.
- 9. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative.
- 10. Written informed consent.
Who cannot join
- 1.Known history of hypersensitivity to any components of the Tislelizumab formulation, or other monoclonal antibody.
- 2.Prior therapy with any anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody, anti-IgE monoclonal antibody, or other monoclonal antibodies/biological agents.
- 3.There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE5.0 occurred within 4 weeks before screening.
- 4.Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery / vein), nasopharyngeal necrosis, or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.
- 5.Patients with abnormal blood coagulation and bleeding tendency (14 days before signing informed consent: INR is within the normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues. On the premise that the INR < 1.5, low-dose warfarin (1mg orally, once a day) or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive purposes.
- 6.Arteriovenous thrombosis occurred within one year before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by intravenous catheterization due to early chemotherapy) and pulmonary embolism.
Show all 19Show fewer
- 7. Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix.
- 8. Join another clinical study at the same time, received any research drug within 4 weeks before the first administration of the drug.
- 9. Patients with any active autoimmune disease or a documented history of autoimmune disease such as pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
- 10. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
- 11. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.
- 12. Be known to have active tuberculosis.
- 13. Hepatitis B virus (HBV) >2000 IU/ml or DNA ≥ 1×10^4/ml; or hepatitis C virus (HCV) RNA ≥ 1×10^3/ml).
- 14. Has an active infection requiring systemic therapy.
- 15. Has known active central nervous system metastases.
- 16. Severe, uncontrolled angiocardiopathy (heart failure > class II NYHA, unstable angina, myocardial infarction within past 1 year, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.).
- 17. Have been vaccinated with anti-tumor vaccines or have been vaccinated with live vaccines within 4 weeks before screening.
- 18. Pregnant or nursing.
- 19. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Haiqiang Mai, MD,Ph.D, 86-20-87343380, maihq@sysucc.org.cn
About this study
Official title: Efficacy and Safety of Scipibaimab Combined With Tislelizumab in the Treatment of Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma Who Have Failed First-line Treatment: a Multicenter, Single-arm, Non-randomized, Open-label Phase II Clinical Study
This study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy.
Read the detailed description
In the immunotherapy era, patients with recurrent/metastatic nasopharyngeal carcinoma who progress after both platinum-based chemotherapy and PD-1 blockade lack further standard options. IL-4Rα inhibition can overcome PD-1 resistance by re-activating CD8+ T cells; combining scipibaimab (anti-IL-4Rα) with tislelizumab (anti-PD-1) has shown additive activity without overlapping toxicity. This trial will assess the efficacy and safety of the combination in patients who have failed prior platinum and PD-1 therapy.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Tislelizumab, Scipibaimab
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Anti-PD-1 targeted immunotherapy
ScipibaimabDrug
Scipibaimab (CM310) is a humanized IgG4 monoclonal antibody that selectively binds to a unique epitope on human IL-4Rα, thereby simultaneously blocking IL-4 and IL-13 signaling without competing with dupilumab's binding site; it exhibits cross-species reactivity (human, cynomolgus monkey, rat), displays linear pharmacokinetics with an estimated terminal half-life of ~300 h in monkeys, and has shown favorable safety and dose-proportional exposure in multiple Phase 1-3 trials for type-2 inflammatory diseases .
| Study group | Role | What they receive |
|---|---|---|
| Scipibaimab combined with Tislelizumab | Experimental | Patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line platinum-based chemotherapy plus PD-1 inhibition will receive scipibaimab 300 mg subcutaneous and tislelizumab 200 mg intravenous every 3 weeks until disease progression, unacceptable toxicity, or completion of 2-year treatment window. Receives: Drug: Tislelizumab; Drug: Scipibaimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI)
Measured: 2 years
Secondary outcomes (5)
Disease control rate
A disease control rate is defined as either a confirmed CR or a PR or a SD, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI).
Measured: 2 years
Duration of response
Defined from date of first confirmed CR or a PR to date of first documentation of progression or death due to any cause, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI).
Measured: 2 years
Progression-free survival rate
Defined from date of registration to date of first documentation of progression or death due to any cause.
Measured: 2 years
Overall survival rate
Defined from date of registration to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 2 years
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events (acute toxicity) as assessed by CTCAE v5.0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Cancer Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388758
- Sponsor's protocol ID
- 2025-FXY-070
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.
PubMed 37499670Zhang Y, Yan B, Shen S, Song X, Jiang Y, Shi L, Zhao C, Yang Y, Jiang L, Li J, Ye J, Liu J, Wan L, Yang Y, Chen J, Liu F, Su L, Xu Y, Tan G, Yu S, Zhang Y, Wang L, Liu S, Yan H, Liu W, Chen B, Wang C, Zhang L. Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial. EClinicalMedicine. 2023 Jul 5;61:102076. doi: 10.1016/j.eclinm.2023.102076. eCollection 2023 Jul.
PubMed 37483544Ng WT, Lee MC, Chang AT, Chan OS, Chan LL, Cheung FY, Hung WM, Chan CC, Lee AW. The impact of dosimetric inadequacy on treatment outcome of nasopharyngeal carcinoma with IMRT. Oral Oncol. 2014 May;50(5):506-12. doi: 10.1016/j.oraloncology.2014.01.017. Epub 2014 Feb 13.
PubMed 24529762Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Scipibaimab Combined With Tislelizumab in the Treatment of Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma Who Have Failed First-line Treatment: a Multicenter, Single-arm, Non-randomized, Open-label Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07388758
- Acronym / sponsor ID
- 2025-FXY-070
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Cancer Hospital of Guangxi Medical University
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Feb 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 study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy.
Detailed description
In the immunotherapy era, patients with recurrent/metastatic nasopharyngeal carcinoma who progress after both platinum-based chemotherapy and PD-1 blockade lack further standard options. IL-4Rα inhibition can overcome PD-1 resistance by re-activating CD8+ T cells; combining scipibaimab (anti-IL-4Rα) with tislelizumab (anti-PD-1) has shown additive activity without overlapping toxicity. This trial will assess the efficacy and safety of the combination in patients who have failed prior platinum and PD-1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scipibaimab combined with Tislelizumab | Experimental | Drug: Tislelizumab, Drug: ScipibaimabPatients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line platinum-based chemotherapy plus PD-1 inhibition will receive scipibaimab 300 mg subcutaneous and tislelizumab 200 mg intravenous every 3 weeks until disease progression, unacceptable toxicity, or completion of 2-year treatment window. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy.
- 2. Age ≥ 18 years and ≤ 75 years, both genders.
- 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- 4. Life expectancy of at least 3 months.
- 5. Have failed for first-line platinum-based chemotherapy.
Key exclusion criteria (19 listed)
- 1.Known history of hypersensitivity to any components of the Tislelizumab formulation, or other monoclonal antibody.
- 2.Prior therapy with any anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody, anti-IgE monoclonal antibody, or other monoclonal antibodies/biological agents.
- 3.There was a history of severe bleeding, and any bleeding events with a serious grade of 3 or more in CTCAE5.0 occurred within 4 weeks before screening.
- 4.Before treatment, MRI showed that the tumor may have invaded important blood vessels (such as enclosing the internal carotid artery / vein), nasopharyngeal necrosis, or researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment.
- 5.Patients with abnormal blood coagulation and bleeding tendency (14 days before signing informed consent: INR is within the normal range without anticoagulant); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues. On the premise that the INR < 1.5, low-dose warfarin (1mg orally, once a day) or low-dose aspirin (daily dose not more than 100mg) is allowed for preventive purposes.
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 |
|---|---|---|
| TislelizumabAnti-PD-1 targeted immunotherapy | Drug | Scipibaimab combined with Tislelizumab |
| ScipibaimabScipibaimab (CM310) is a humanized IgG4 monoclonal antibody that selectively binds to a unique epitope on human IL-4Rα, thereby simultaneously blocking IL-4 and IL-13 signaling without competing with dupilumab's binding site; it exhibits cross-species reactivity (human, cynomolgus monkey, rat), displays linear pharmacokinetics with an estimated terminal half-life of ~300 h in monkeys, and has shown favorable safety and dose-proportional exposure in multiple Phase 1-3 trials for type-2 inflammatory diseases . | Drug | Scipibaimab combined with Tislelizumab |
Primary outcome
Objective response rate
Time frame: 2 years
An objective response is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST1.1) from the National Cancer Institute (NCI)
5 secondary outcomes
Disease control rate
Time frame: 2 years
Duration of response
Time frame: 2 years
Progression-free survival rate
Time frame: 2 years
Overall survival rate
Time frame: 2 years
Incidence rate of adverse events (AEs)
Time frame: 2 years
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 5 Feb 2026.
- Results publication: PubMed 37499670Qin S, Chan SL, Gu S, Bai Y, Ren Z, Lin X, Chen Z, Jia W, Jin Y, Guo Y, Hu X, Meng Z, Liang J, Cheng Y, Xiong J, Ren H, Yang F, Li W, Chen Y, Zeng Y, Sultanbaev A, Pazgan-Simon M, Pisetska M, Melisi D, Ponomarenko D, Osypchuk Y, Sinielnikov I, Yang TS, Liang X, Chen C, Wang L, Cheng AL, Kaseb A, Vogel A; CARES-310 Study Group. Camrelizumab plus rivoceranib versus sorafenib as first-line therapy for unresectable hepatocellular carcinoma (CARES-310): a randomised, open-label, international phase 3 study. Lancet. 2023 Sep 30;402(10408):1133-1146. doi: 10.1016/S0140-6736(23)00961-3. Epub 2023 Jul 24.
- Results publication: PubMed 37483544Zhang Y, Yan B, Shen S, Song X, Jiang Y, Shi L, Zhao C, Yang Y, Jiang L, Li J, Ye J, Liu J, Wan L, Yang Y, Chen J, Liu F, Su L, Xu Y, Tan G, Yu S, Zhang Y, Wang L, Liu S, Yan H, Liu W, Chen B, Wang C, Zhang L. Efficacy and safety of CM310 in severe eosinophilic chronic rhinosinusitis with nasal polyps (CROWNS-1): a multicentre, randomised, double-blind, placebo-controlled phase 2 clinical trial. EClinicalMedicine. 2023 Jul 5;61:102076. doi: 10.1016/j.eclinm.2023.102076. eCollection 2023 Jul.
- Results publication: PubMed 24529762Ng WT, Lee MC, Chang AT, Chan OS, Chan LL, Cheung FY, Hung WM, Chan CC, Lee AW. The impact of dosimetric inadequacy on treatment outcome of nasopharyngeal carcinoma with IMRT. Oral Oncol. 2014 May;50(5):506-12. doi: 10.1016/j.oraloncology.2014.01.017. Epub 2014 Feb 13.
- Results publication: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Results publication: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- 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 2 study testing Tislelizumab and Scipibaimab in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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?
Contact Haiqiang Mai (86-20-87343380, maihq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 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 NCT07388758, which also lists 5 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 5 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.