Non-small Cell Lung CarcinomaPhase 1NCT04000529
Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
A Phase 1 study testing TNO155, Spartalizumab and Ribociclib in people with Non-small Cell Lung Carcinoma and Head and Neck Squamous Cell Carcinoma, run by Novartis Pharmaceuticals at 10 sites in 9 countries.
Trial summary
This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC
- What is being tested?
- TNO155, Spartalizumab and Ribociclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 10 sitesin 9 countries
- Study dates
- 30 Jul 2019to 15 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Signed informed consent must be obtained prior to participation in the study.
- Age ≥ 18 years. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.
- Dose escalation part: Patients with advanced solid tumors, with evaluable disease as determined by RECIST version 1.1, and fit into one of the following groups:
- For TNO155 plus spartalizumab combination: i. Advanced EGFR WT, ALK WT NSCLC, after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy.
- Advanced HNSCC or esophageal SCC, after progression on or intolerance to platinum-containing combination chemotherapy.
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- Advanced CRC, after progression on or intolerance to all standard-of-care (SOC) therapy per local guidelines.
- For TNO155 plus ribociclib combination: Advanced solid malignancies with the exception of CRC or GIST, after progression on or intolerance to all SOC therapy per local guidelines. The exclusion of CRC applies only as of Protocol Amendment 4.
- Dose expansion part: Patients with advanced solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who fit into one of the following groups:
- For TNO155 plus spartalizumab combination: i. Advanced EGFR WT, ALK WT, KRAS G12C NSCLC after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy.
- Advanced EGFR WT, ALK WT, KRAS WT NSCLC, after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy.
- Advanced HNSCC, after progression on or intolerance to, platinum-containing combination chemotherapy.
- For TNO155 plus ribociclib combination: i. Advanced EGFR WT, ALK WT, KRAS WT NSCLC, after progression on or intolerance to platinum-containing chemotherapy and anti-PD-1 or anti-PD-L1 therapy ii. Advanced HNSCC, after progression on or intolerance to all SOC per local guidelines
- Patients with NSCLC whose tumors harbor genomic aberrations for which SOC targeted therapies exist and are locally approved and available must have had progression on or after, or intolerance to, the SOC targeted therapy/therapies as indicated
- Patients must have a site of disease amenable to biopsy
Who cannot join
- Prior treatment with a MAPK pathway inhibitor
- Clinically significant cardiac disease or risk factors
- Use of any agent known to prolong the QT interval unless it can be permanently discontinued for the duration of study (see list in Section 6.2.2).
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs
- Symptomatic CNS metastases which are neurologically unstable
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- Insufficient bone marrow function at screening:
- Absolute Neutrophil Count (ANC) < 1.5 x 109/L.
- Hemoglobin < 9.0 g/dL.
- Platelets < 75 x 109/L for TNO155 plus spartalizumab combination; < 100 x 109/L for TNO155 plus ribociclib combination.
- Insufficient hepatic or renal function at screening:
- Serum total bilirubin > upper limit of normal (ULN) or, for TNO155 plus spartalizumab combination only, if liver metastases are present at baseline, serum total bilirubin > 1.5 x ULN. An exception for either combination is for patients with Gilbert's syndrome, who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x ULN for TNO155 plus spartalizumab combination or > 2.5 x ULN for TNO155 plus ribociclib combination, or > 5 x ULN for either combination if liver metastases are present.
- Creatinine clearance < 60 mL/min (calculated using Cockcroft-Gault equation).
- Pregnant or breast-feeding (lactating) women.
- Additional exclusion criteria for the TNO155 plus spartalizumab combination
- History of severe hypersensitivity reactions to other mAbs.
- Active, known or suspected autoimmune disease.
- History of or current interstitial lung disease or pneumonitis grade ≥ 2.
- Human Immunodeficiency Virus (HIV) infection, unless the patient is on antiviral therapy and has undetectable viral load.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Systemic chronic steroid therapy
- Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity.
- Additional exclusion criteria for the TNO155 plus ribociclib combination
- Systolic Blood Pressure (SBP) < 90 mmHg.
- International Normalized Ratio (INR) > 1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within seven days prior to the first dose of study drug).
- History of HIV infection (testing not mandatory)
- Currently receiving any of the following substances and cannot be discontinued seven days prior to Cycle 1 Day 1:
- Concomitant medications or herbal supplements, that are strong inducers or inhibitors of CYP3A4/5,
- Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Previous treatment with a CDK4/6 inhibitor.
- Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
- Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Valencia, Valencia, 46010
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.
These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.
The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.
Read the detailed description
Rationale The purpose of this study was to evaluate the safety, tolerability, and preliminary efficacy of the combination of TNO155 with spartalizumab and of TNO155 with ribociclib, and to identify dosing regimens for further study. Data from preclinical models have demonstrated anti-tumor activity for the combinations of TNO155 with spartalizumab and of TNO155 with ribociclib that is superior to the activity observed with each of the drugs as single agents. These data suggest that these combinations may provide clinical benefit to patients with advanced malignancies.
Study Design This study was a Phase Ib, multi-center, open-label study with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors to characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib and to identify the MTD and/or recommended regimen (dose and schedule) for each combination. The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.
Objectives
Primary objective:
To characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib, and to identify the MTD and/or recommended regimen (dose and schedule) for each combination.
Secondary objectives:
- To characterize the pharmacokinetic (PK) profile of TNO155, spartalizumab and ribociclib when administered as a combination of TNO155 plus spartalizumab or of TNO155 plus ribociclib.
- To evaluate the preliminary anti-tumor activity of TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib.
- Conditions
- Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC, Gastrointestinal Stromal Tumors, Colorectal Cancer
- Being tested
- TNO155, Spartalizumab, Ribociclib
- Keywords
- TNO155, spartalizumab, ribociclib, checkpoint inhibitor, SHP2, PD-1, CDK4/6, NSCLC, CRC, HNSCC, KRAS, esophageal SCC, GIST
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Gastrointestinal Stromal Tumors, Colorectal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNO155Drug
Capsule
SpartalizumabDrug
Also called PDR001
Concentrate for solution for infusion
RibociclibDrug
Also called LEE011
Capsule and tablet
| Study group | Role | What they receive |
|---|---|---|
| TNO155 in combination with spartalizumab | Experimental | TNO155 in combination with spartalizumab Receives: Drug: TNO155; Drug: Spartalizumab |
| TNO155 in combination with ribociclib | Experimental | TNO155 in combination with ribociclib Receives: Drug: TNO155; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT incidence
Incidence of dose limiting toxicities (DLTs) during the first cycle of combination treatment during the dose escalation part
Measured: 1 year
AE and SAE incidence
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as per CTCAE v5.0, by treatment
Measured: 3 years
Dose interruptions, reductions and dose intensity, by treatment
Dose tolerability
Measured: 3 years
Secondary outcomes (13)
Pharmacokinetics (PK): Cmax
Cmax for TNO155, spartalizumab, and ribociclib
Measured: 3 years
Pharmacokinetics (PK): Tmax
Tmax for TNO155, spartalizumab, and ribociclib
Measured: 3 years
Pharmacokinetics (PK): AUClast
AUClast for TNO155, spartalizumab, and ribociclib
Measured: 3 years
Pharmacokinetics (PK): AUCtau
AUCtau for TNO155, spartalizumab, and ribociclib
Measured: 3 years
Efficacy measurements per RECIST v1.1: ORR
Overall response rate (ORR) per RECIST v1.1, by treatment
Measured: 3 years
Efficacy measurements per RECIST v1.1: DCR
Disease control rate (DCR) per RECIST v1.1, by treatment
Measured: 3 years
Efficacy measurements per RECIST v1.1: PFS
Progression-free survival (PFS) per RECIST v1.1, by treatment
Measured: 3 years
Efficacy measurements per RECIST v1.1: DOR
Duration of response (DOR) per RECIST v1.1, by treatment
Measured: 3 years
Efficacy measurements per iRECIST: ORR
Overall response rate (ORR) per iRECIST for TNO155 in combination with spartalizumab
Measured: 3 years
Efficacy measurements per iRECIST: DCR
Disease control rate (DCR) per iRECIST for TNO155 in combination with spartalizumab
Measured: 3 years
Efficacy measurements per iRECIST: PFS
Progression-free survival (PFS) per iRECIST for TNO155 in combination with spartalizumab
Measured: 3 years
Efficacy measurements per iRECIST: DOR
Duration of response (DOR) per iRECIST for TNO155 in combination with spartalizumab
Measured: 3 years
Overall Survival
Overall survival (OS) by treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start30 Jul 2019
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000529
- Sponsor's protocol ID
- CTNO155B12101
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2019
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen H, Cresswell GM, Libring S, Ayers MG, Miao J, Zhang ZY, Solorio L, Ratliff TL, Wendt MK. Tumor Cell-Autonomous SHP2 Contributes to Immune Suppression in Metastatic Breast Cancer. Cancer Res Commun. 2022 Oct 3;2(10):1104-1118. doi: 10.1158/2767-9764.CRC-22-0117. eCollection 2022 Oct.
PubMed 36969745
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
- ClinicalTrials.gov ID
- NCT04000529
- Acronym / sponsor ID
- CTNO155B12101
- Conditions
- Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC, Gastrointestinal Stromal Tumors, Colorectal Cancer
- Keywords
- TNO155, spartalizumab, ribociclib, checkpoint inhibitor, SHP2, PD-1, CDK4/6, NSCLC, CRC, HNSCC, KRAS, esophageal SCC, GIST
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 27 Jun 2019 (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 was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.
These two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.
The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.
Detailed description
Rationale The purpose of this study was to evaluate the safety, tolerability, and preliminary efficacy of the combination of TNO155 with spartalizumab and of TNO155 with ribociclib, and to identify dosing regimens for further study. Data from preclinical models have demonstrated anti-tumor activity for the combinations of TNO155 with spartalizumab and of TNO155 with ribociclib that is superior to the activity observed with each of the drugs as single agents. These data suggest that these combinations may provide clinical benefit to patients with advanced malignancies.
Study Design This study was a Phase Ib, multi-center, open-label study with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors to characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib and to identify the MTD and/or recommended regimen (dose and schedule) for each combination. The study treatment was administered until the subject experienced unacceptable toxicity, progressive disease, and/or had treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.
Objectives
Primary objective:
To characterize the safety and tolerability TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib, and to identify the MTD and/or recommended regimen (dose and schedule) for each combination.
Secondary objectives:
- To characterize the pharmacokinetic (PK) profile of TNO155, spartalizumab and ribociclib when administered as a combination of TNO155 plus spartalizumab or of TNO155 plus ribociclib.
- To evaluate the preliminary anti-tumor activity of TNO155 in combination with spartalizumab and of TNO155 in combination with ribociclib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNO155 in combination with spartalizumab | Experimental | Drug: TNO155, Drug: SpartalizumabTNO155 in combination with spartalizumab |
| TNO155 in combination with ribociclib | Experimental | Drug: TNO155, Drug: RibociclibTNO155 in combination with ribociclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Age ≥ 18 years. For Japan only: written consent is necessary both from the patient and his/her legal representative if he/she is under the age of 20 years.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1.
- Dose escalation part: Patients with advanced solid tumors, with evaluable disease as determined by RECIST version 1.1, and fit into one of the following groups:
- Dose expansion part: Patients with advanced solid tumors, with at least one measurable lesion as determined by RECIST version 1.1, who fit into one of the following groups:
Key exclusion criteria (33 listed)
- Prior treatment with a MAPK pathway inhibitor
- Clinically significant cardiac disease or risk factors
- Use of any agent known to prolong the QT interval unless it can be permanently discontinued for the duration of study (see list in Section 6.2.2).
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs
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 |
|---|---|---|
| TNO155Capsule | Drug | TNO155 in combination with ribociclib, TNO155 in combination with spartalizumab |
| SpartalizumabAlso: PDR001Concentrate for solution for infusion | Drug | TNO155 in combination with spartalizumab |
| RibociclibAlso: LEE011Capsule and tablet | Drug | TNO155 in combination with ribociclib |
Primary outcome
DLT incidence
Time frame: 1 year
Incidence of dose limiting toxicities (DLTs) during the first cycle of combination treatment during the dose escalation part
AE and SAE incidence
Time frame: 3 years
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as per CTCAE v5.0, by treatment
Dose interruptions, reductions and dose intensity, by treatment
Time frame: 3 years
Dose tolerability
13 secondary outcomes
Pharmacokinetics (PK): Cmax
Time frame: 3 years
Pharmacokinetics (PK): Tmax
Time frame: 3 years
Pharmacokinetics (PK): AUClast
Time frame: 3 years
Pharmacokinetics (PK): AUCtau
Time frame: 3 years
Efficacy measurements per RECIST v1.1: ORR
Time frame: 3 years
Efficacy measurements per RECIST v1.1: DCR
Time frame: 3 years
Efficacy measurements per RECIST v1.1: PFS
Time frame: 3 years
Efficacy measurements per RECIST v1.1: DOR
Time frame: 3 years
Efficacy measurements per iRECIST: ORR
Time frame: 3 years
Efficacy measurements per iRECIST: DCR
Time frame: 3 years
Efficacy measurements per iRECIST: PFS
Time frame: 3 years
Efficacy measurements per iRECIST: DOR
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 36969745Chen H, Cresswell GM, Libring S, Ayers MG, Miao J, Zhang ZY, Solorio L, Ratliff TL, Wendt MK. Tumor Cell-Autonomous SHP2 Contributes to Immune Suppression in Metastatic Breast Cancer. Cancer Res Commun. 2022 Oct 3;2(10):1104-1118. doi: 10.1158/2767-9764.CRC-22-0117. eCollection 2022 Oct.
- Study ResultsLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNO155, Spartalizumab and Ribociclib in people with Non-small Cell Lung Carcinoma and Head and Neck Squamous Cell Carcinoma, run by Novartis Pharmaceuticals at 10 sites in 9 countries.
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 15 inclusion and 33 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: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, United States, Australia, Belgium, China and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
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?
DLT incidence (time frame: 1 year). The study lists 3 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 NCT04000529, which also lists 1 linked publication.
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 30 Sep 2025.