Metastatic Non Small Cell Lung CancerPhase 1/2ADIVO LungNCT05236608
A Study to Evaluate the Combination of Nivolumab With ADG106 in Metastatic NSCLC
A Phase 1/2 study testing Nivolumab and ADG106 in people with Metastatic Non Small Cell Lung Cancer, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Metastatic Non Small Cell Lung Cancer
- What is being tested?
- Nivolumab and ADG106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesSingapore
- Study dates
- 12 Nov 2021to May 2024
- Phase
- Phase 1/2
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Phase 1b: Patients with histologically or cytologically confirmed solid malignancies
- who are refractory to standard of care treatment OR
- have no standard of care treatment of curative potential.
- For Phase 2: Patients with histologically or cytologically confirmed stage 4 or recurrent NSCLC (per IASLC classification) who have progression of disease
- after treatment with antiPD1/PDL1 with CTLA4 inhibitors and at least one platinum-based chemotherapy OR
- after treatment with antiPD1/PDL1 without CTLA4 inhibitors and at least one platinum-based chemotherapy
Show all 17Show fewer
- The participant (or legally acceptable representative if applicable) provides written consent for the trial.
- Participants who are at least 21 years of age on the day of signing informed consent.
- Eastern Cooperative Group (ECOG) Performance Status 0-1
- Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Previously irradiated lesions is considered measurable if they show progression after completion of radiation therapy.
- Have adequate organ function. Specimens must be collected within 7 days prior to the start of study treatment.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential OR
- A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study medication.
- A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- Willing to participate in the translational blood and tissue collection studies.
- Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumour tissue block or unstained tumour tissue specimens if fresh tumour biopsy is not feasible.
Who cannot join
- Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to enrolment.
- Note: Participants must have recovered from all AEs to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Prior severe immune adverse events of grade 3 or 4 to antiPD1/PDL1 therapy. These include interstitial pneumonitis.
- Has a known history of active TB (Mycobacterium tuberculosis).
Show all 20Show fewer
- Known allergy to any of the ingredients of ADG106 (succinic acid, arginine, polysorbate 80 and hydrochloric acid) in the formulation or known allergy to any related class of compounds (note: polysorbate 80 is an ingredient in docetaxel).
- Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
- Known brain metastases or leptomeningeal metastases that are not adequately treated and require corticosteroids of > 10mg daily prednisolone or its equivalent at least 7 days prior to study treatment start date.
- Has an active infection requiring systemic therapy.
- History of having received a live virus vaccination (eg yellow fever, MMR, nasal flu, chicken pox or Zostavax) in the past 1 month.
- Subjects with underlying hemoglobinopathies (e.g., thalassemia).
- Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrolment. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Subjects with active hepatitis B (positive hepatitis B surface antigen [HBsAg] with detectable serum HBV DNA) or HCV (hepatitis C virus) [positive HCV RNA]). Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to enrolment. HBsAg positive carriers or those patients with undetectable serum HBV DNA and on antiviral therapy are eligible to participate. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Known history of testing positive for human immunodeficiency virus (HIV) or Known history of testing positive for known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Not yet recruiting
National Cancer Centre Singapore
Singapore, 169610
Daniel Tan, MBBS, MRCP, PhD, 65-6436-8000, daniel.tan.s.w@singhealth.com.sg
- Recruiting
National University Hospital
Singapore
Boon Cher Goh, MBBS, MRCP, MMed, FAMS, 65-6772-4617, boon_cher_goh@nuhs.com.sg
About this study
Official title: A Phase 1b/2 Study to Evaluate the Combination of Nivolumab (Anti PD1 Monoclonal Ab) With ADG106 (4-1-BB Agonist Monoclonal Ab) in Metastatic NSCLC After Progression With antiPD1 Therapy and Platinum-based Chemotherapy (ADIVO Lung Study)
This is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB.
The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Being tested
- Nivolumab, ADG106
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Administered together with ADG106 via intravenous infusion.
ADG106Drug
Administered as an intravenous infusion over 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab and ADG106 | Experimental | Eligible patients will receive nivolumab and ADG106 by IV infusion according to the study phases below.
Phase 1b:
3 evaluable patients will be treated at the starting dose, and assessed for tolerability over the first cycle. Treatment related dose-limiting toxicities (DLT) will determine the next dose level to be studied. Dose escalation will follow the 3 + 3 study dose titration design.
Phase 2:
The dose of ADG106 given together with nivolumab will be the recommended dose in combination with nivolumab determined in phase 1b. Receives: Drug: Nivolumab; Drug: ADG106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Adverse events profile, safety profile of the combination of ADG106 and nivolumab according to the NCI Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Measured: 45 months
Objective response rate
Objective response rate (CR + PR) using RECIST 1.1 of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2).
Measured: 24 months
Secondary outcomes (3)
Progression free survival at 6 months
Progression free survival at 6 months of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2) and the irRECIST objective response rate.
Measured: 6 months
Area Under the Curve [AUC]
Pharmacokinetics of nivolumab/ADG106 will be measured using blood samples collected at specify timepoint
Measured: Baseline until Cycle 2 Day 1, each cycle is 21 days
Maximum Plasma Concentration [Cmax]
Pharmacokinetics of nivolumab/ADG106 will be measured using blood samples collected at specify timepoint
Measured: Baseline until Cycle 2 Day 1, each cycle is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start12 Nov 2021
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Adagene Inc, Bristol-Myers Squibb, Singapore Translational Cancer Consortium
- Responsible party
- Sponsor
- Investigators
- Boon Cher Goh, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236608
- Sponsor's protocol ID
- STCC-02
- Other IDs
- CA209-63C, ADG106-T6001
- Acronym
- ADIVO Lung
- Status last verified
- Mar 2022
- First submitted
- 11 Oct 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Paulete AR, Labiano S, Rodriguez-Ruiz ME, Azpilikueta A, Etxeberria I, Bolanos E, Lang V, Rodriguez M, Aznar MA, Jure-Kunkel M, Melero I. Deciphering CD137 (4-1BB) signaling in T-cell costimulation for translation into successful cancer immunotherapy. Eur J Immunol. 2016 Mar;46(3):513-22. doi: 10.1002/eji.201445388. Epub 2016 Feb 9.
PubMed 26773716Costantini A, Corny J, Fallet V, Renet S, Friard S, Chouaid C, Duchemann B, Giroux-Leprieur E, Taillade L, Doucet L, Nguenang M, Jouveshomme S, Wislez M, Tredaniel J, Cadranel J. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2):00120-2017. doi: 10.1183/23120541.00120-2017. eCollection 2018 Apr.
PubMed 29692997Freeman AT, Lesperance M, Wai ES, Croteau NS, Fiorino L, Geller G, Brooks EG, Poonja Z, Fenton D, Irons S, Ksienski D. Treatment of non-small-cell lung cancer after progression on nivolumab or pembrolizumab. Curr Oncol. 2020 Apr;27(2):76-82. doi: 10.3747/co.27.5495. Epub 2020 May 1.
PubMed 32489249Qi X, Li F, Wu Y, Cheng C, Han P, Wang J, Yang X. Optimization of 4-1BB antibody for cancer immunotherapy by balancing agonistic strength with FcgammaR affinity. Nat Commun. 2019 May 20;10(1):2141. doi: 10.1038/s41467-019-10088-1.
PubMed 31105267
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study to Evaluate the Combination of Nivolumab (Anti PD1 Monoclonal Ab) With ADG106 (4-1-BB Agonist Monoclonal Ab) in Metastatic NSCLC After Progression With antiPD1 Therapy and Platinum-based Chemotherapy (ADIVO Lung Study)
- ClinicalTrials.gov ID
- NCT05236608
- Acronym / sponsor ID
- ADIVO Lung / STCC-02
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Adagene Inc, Bristol-Myers Squibb, Singapore Translational Cancer Consortium
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 11 Feb 2022 (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 is an open label, non-randomised phase 1b/2 study including patients with non-small cell lung cancer who have progressed after treatment with immune checkpoint inhibitors (anti PD1/PDL1 with or without CTLA4 inhibitors) and platinum-based chemotherapy. The study medications include nivolumab, an anti-PD1 inhibitor and ADG106, an agonist antibody of 4-1-BB.
The investigators hypothesize that the combination of nivolumab and ADG106 would be tolerable, and demonstrate significant clinical anti-tumour activity in patients with NSCLC that has failed antiPD1/antiPDL1 immunotherapy and standard platinum-based chemotherapy. The investigators propose to conduct a phase 1b/2 study to investigate this strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab and ADG106 | Experimental | Drug: Nivolumab, Drug: ADG106Eligible patients will receive nivolumab and ADG106 by IV infusion according to the study phases below. Phase 1b: 3 evaluable patients will be treated at the starting dose, and assessed for tolerability over the first cycle. Treatment related dose-limiting toxicities (DLT) will determine the next dose level to be studied. Dose escalation will follow the 3 + 3 study dose titration design. Phase 2: The dose of ADG106 given together with nivolumab will be the recommended dose in combination with nivolumab determined in phase 1b. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- For Phase 1b: Patients with histologically or cytologically confirmed solid malignancies
- For Phase 2: Patients with histologically or cytologically confirmed stage 4 or recurrent NSCLC (per IASLC classification) who have progression of disease
- The participant (or legally acceptable representative if applicable) provides written consent for the trial.
- Participants who are at least 21 years of age on the day of signing informed consent.
- Eastern Cooperative Group (ECOG) Performance Status 0-1
Key exclusion criteria (20 listed)
- Has received prior systemic anti-cancer therapy including investigational agents within 3 weeks prior to enrolment.
- Note: Participants must have recovered from all AEs to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Prior severe immune adverse events of grade 3 or 4 to antiPD1/PDL1 therapy. These include interstitial pneumonitis.
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 |
|---|---|---|
| NivolumabAlso: OpdivoAdministered together with ADG106 via intravenous infusion. | Drug | Nivolumab and ADG106 |
| ADG106Administered as an intravenous infusion over 90 minutes. | Drug | Nivolumab and ADG106 |
Primary outcome
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: 45 months
Adverse events profile, safety profile of the combination of ADG106 and nivolumab according to the NCI Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).
Objective response rate
Time frame: 24 months
Objective response rate (CR + PR) using RECIST 1.1 of the combination of ADG106 and nivolumab in patients with metastatic NSCLC that have progressed after antiPD1/PDL1 treatment and platinum-based chemotherapy (phase 2).
3 secondary outcomes
Progression free survival at 6 months
Time frame: 6 months
Area Under the Curve [AUC]
Time frame: Baseline until Cycle 2 Day 1, each cycle is 21 days
Maximum Plasma Concentration [Cmax]
Time frame: Baseline until Cycle 2 Day 1, each cycle is 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Results publication: PubMed 26773716Sanchez-Paulete AR, Labiano S, Rodriguez-Ruiz ME, Azpilikueta A, Etxeberria I, Bolanos E, Lang V, Rodriguez M, Aznar MA, Jure-Kunkel M, Melero I. Deciphering CD137 (4-1BB) signaling in T-cell costimulation for translation into successful cancer immunotherapy. Eur J Immunol. 2016 Mar;46(3):513-22. doi: 10.1002/eji.201445388. Epub 2016 Feb 9.
- Results publication: PubMed 29692997Costantini A, Corny J, Fallet V, Renet S, Friard S, Chouaid C, Duchemann B, Giroux-Leprieur E, Taillade L, Doucet L, Nguenang M, Jouveshomme S, Wislez M, Tredaniel J, Cadranel J. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2):00120-2017. doi: 10.1183/23120541.00120-2017. eCollection 2018 Apr.
- Results publication: PubMed 32489249Freeman AT, Lesperance M, Wai ES, Croteau NS, Fiorino L, Geller G, Brooks EG, Poonja Z, Fenton D, Irons S, Ksienski D. Treatment of non-small-cell lung cancer after progression on nivolumab or pembrolizumab. Curr Oncol. 2020 Apr;27(2):76-82. doi: 10.3747/co.27.5495. Epub 2020 May 1.
- Results publication: PubMed 31105267Qi X, Li F, Wu Y, Cheng C, Han P, Wang J, Yang X. Optimization of 4-1BB antibody for cancer immunotherapy by balancing agonistic strength with FcgammaR affinity. Nat Commun. 2019 May 20;10(1):2141. doi: 10.1038/s41467-019-10088-1.
- Individual participant dataSharing planned: No
Related trials for Metastatic Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Boon Cher Goh principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab and ADG106 in people with Metastatic Non Small Cell Lung Cancer, run by National University Hospital, Singapore at 2 sites in Singapore.
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 17 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boon Cher Goh (+65 6772 4617, boon_cher_goh@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: 45 months). The study lists 2 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 NCT05236608, which also lists 4 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 25 Mar 2022.