Non-small Cell Lung CancerPhase 1/2NCT05257512

Phase I/II Study of SY-3505 in Patients With ALK-positive Advanced Non-small Cell Lung Cancer

A Phase 1/2 study testing SY-3505 in people with Non-small Cell Lung Cancer, run by Shouyao Holdings (Beijing) Co. LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This is a phase I/II, open-label and multi-center study of SY-3505, a third-generation ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer (ALK-positive NSCLC). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: SY-3505
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteChina
Study dates: 26 Apr 2020to 26 Aug 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age ≥ 18 years at the time of screening.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Estimated Life expectancy ≥ 12 weeks.
Must have either at least one measurable lesion with no prior local treatment or measurable lesions with definite progression (Bone metastases alone were not accepted) after local treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Dose-escalation phase: patients must have histological or cytological confirmed ALK-positive advanced NSCLC. Dose-expansion phase: patients must have histological or cytological confirmed ALK-positive advanced NSCLC and progressed after at least one prior line of ALK TKI therapy. Phase II: patients must have histological or cytological confirmed ALK-positive advanced NSCLC and progressed after only alectinib or ≥2 prior ALK TKIs treatment. The pathological report requires either positivity for ALK gene expression determined by fluorescence in-situ hybridization (FISH) assay, immunohistochemistry (IHC), reverse transcription-polymerase chain reaction (RT-PCR), next-generation sequencing (NGS) or other identified methods from previous reports and provide tissue for ALK retest if possible or providing tissue for ALK test if no previous report is available.
Patients without brain metastasis or with asymptomatic brain metastases (no need for intervention or stable more than 4 weeks after treated).

Show all 24Show fewer

Adequate organ function within 10 days prior to the study of treatment as defined in the below:
Hepatic function
Total serum bilirubin (TBIL) ≤ 1.5 times upper limit of normal (ULN); Aspartate transaminase (AST), alanine transaminase (ALT) and γ- glutamyltransferase (GGT) ≤ 2.5 times ULN if no demonstrable liver metastases, or otherwise ≤ 5 times ULN.
Bone marrow function
Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L; Platelets (PLT) count ≥ 100 x 10⁹/L; Hemoglobin (Hb) ≥ 90 g/L.
Renal function
Creatinine clearance ≥ 60 mL/min.
Pancreatic function
Serum total amylase ≤1.5 times ULN; Serum lipase ≤ 1.5 times ULN.
Blood glucose
Fasting Blood Glucose (FBG) ≤ 200 mg/dL (11.1 mmol/L).
Serum lipid
Serum cholesterol ≤ 500 mg/dL (12.92 mmol/L).
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%.
Any toxicity of previous antineoplastic treatments was restored to ≤ 1 (except hair loss).
Female patients with reproductive potential must have a negative serum pregnancy test, male and female patients of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception during the entire study duration and for at least 3 months after the last dose of study medication.
Willingness and ability to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.

Who cannot join

Any of the following within 6 months prior to starting trial treatment: Cerebrovascular accident/ stroke, myocardial infarction, severe/ unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), second- or third- degree atrioventricular (AV) block (unless paced) or any AV block with PR interval >220 msec, or any grade of uncontrolled atrial fibrillation.
ECG evaluated QT interval corrected (Fridericia) (QTcF) of > 450 msec in males or > 470 msec in females or congenital long QT syndrome.
Grade ≥ 3 peripheral neuropathy (CTCAE version 5.0).
Any active autoimmune diseases or history of autoimmune diseases that require long-term steroid or other immunosuppressants treatment.
Previous medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
Patients being treated with any anticoagulants, prone to bleeding, or have a coagulation disorder.

Show all 17Show fewer

Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA ≥ 1000 IU/ml), HIV antibody-positive; Active syphilis.
Patient underwent major surgery within 4 weeks prior to starting trial treatment.
Patients received radical radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks, or radioactive agents (strontium, samarium, etc.) within 8 weeks prior to starting trial treatment.
Patients received systemic antitumor therapy, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokine or cancer growth control factor), or clearly indicated antitumor traditional Chinese medicine within 4 weeks (targeted therapy within 2 weeks) prior to starting trial treatment.
Patients treated with the following drugs and could not be discontinued at least 7 days prior to starting trial treatment and during the entire study duration: drugs known to be strong inducers or suppressors of CYP3A (for details, see prohibited combination drugs in this trial).
Patients with any active infection requiring systemic therapy within 4 weeks prior to starting trial treatment.
Comorbidities that may seriously endanger the patient's safety or affect the completion of the trial, such as severe diabetes, according to the judgment of investigator.
A clear previous history of neurological or psychiatric disorders, including dementia or diagnosed epilepsy for any reason.
With a history (within 5 years) or presence of other malignancies, excluding cured skin basal cell carcinoma and carcinoma in situ of the cervix.
Other situations that may increase the risks related to the study medication, interfere with the interpretation of the study results, affect compliance of the trial, etc. are determined by the investigator to be not suitable for the trial.
In phase II: previously received third-generation ALK TKIs.

Trial locations and contacts

1 site in 1 country.

Yinghui Sun, PhD contact

86-10-88858616

yhsun@centaurusbio.com

China1 site, 1 recruiting

Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, MD, 86-10-87788293, syuankai@cicams.ac.cn
Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Antitumor Activity of SY-3505 Capsule in Patients With ALK-positive Advanced Non-small Cell Lung Cancer

This is a phase I/II, open-label and multi-center study of SY-3505, a third-generation ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer (ALK-positive NSCLC).

Read the detailed description

The study consists of two parts:

Part 1: Dose-escalation and dose-expansion in patients with advanced ALK-positive NSCLC, including 9 SY-3505 dose levels.

Dose-escalation study phase is designed to determine the dose-limiting toxicity (DLT) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of SY-3505. Other dose regimens may be explored based on the analysis of emerging PK and safety data. At this study phase, SY-3505 administered orally once daily (QD) in 28-day treatment cycles to adult patients with ALK-positive NSCLC. Dose-expansion study is designed to evaluate the antitumor activity (ORR, DCR and DoR) of SY-3505 at selected doses in ALK-positive NSCLC patients who have received at least 1 prior ALK TKI therapy.

Part 2: Phase 2 study to evaluate the efficacy of SY-3505.

This phase is designed to determine the antitumor activity (ORR, DCR, DoR, PFS and OS), safety, and PK of SY-3505 at RP2D in ALK-positive NSCLC patients who have received alectinib only or ≥2 prior ALK TKIs.

Conditions: Non-small Cell Lung Cancer
Being tested: SY-3505
Keywords: SY-3505, ALK, NSCLC
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.

SY-3505Drug
Also called CT-3505
The third-generation ALK TKI

Study groups in NCT05257512
Study group	Role	What they receive
Phase I/II Study of SY-3505	Experimental	SY-3505 will be given orally in ascending doses (escalation cohort), until the DLT or RP2D is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose. In phase II, SY-3505 will be given at RP2D in advanced ALK-positive NSCLC patients. Receives: Drug: SY-3505

What is being measured

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

Phase I: Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) in Cycle 1.
Measured: Dose-escalation Cycle 1 (each cycle is 28 days)
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Characterization of the safety and tolerability
Measured: Up to 24 months
Phase II: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Anti-tumor activity of SY-3505
Measured: Up to 24 months

Secondary outcomes (11)

Phase I: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Preliminary anti-tumor activity of SY-3505
Measured: Up to 24 months
Phase I & II: Disease control rate (DCR) as assessed by RECIST 1.1 criteria
Preliminary anti-tumor activity of SY-3505
Measured: Up to 24 months
Phase I & II: Duration of response (DOR)
Anti-tumor activity of SY-3505
Measured: Up to 24 months
Phase I & II: Progression-free survival (PFS)
Anti-tumor activity of SY-3505
Measured: Up to 24 months
Phase I & II: Overall survival (OS)
Anti-tumor activity of SY-3505
Measured: Up to 24 months
Phase I & II: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Characterization of the safety and tolerability
Measured: Up to 24 months
Phase I & II: Pharmacokinetics (Cmax) for SY-3505
Defined as maximum observed plasma concentration
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (Tmax) for SY-3505
Defined as time to maximum plasma concentration
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (AUC0-t) for SY-3505
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (t½) for SY-3505
Defined as the apparent plasma terminal phase disposition half-life
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (Cl/F) for SY-3505
Defined as oral dose clearance
Measured: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Apr 202026 Aug 2024

First posted25 Feb 2022
Study start26 Apr 2020
Primary completion26 Apr 2024 (estimated)
Study completion26 Aug 2024 (estimated)

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 CancerStudies of the same condition, open and under way.
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: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05257512
Sponsor's protocol ID: SY-3505-I
Status last verified: Feb 2023
First submitted: 9 Feb 2022
Last updated: 14 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Shi Y, Hu X, Li X, Gong C, Wang K, Li Y, Zhang S, Luo Y, Wang P, Jiang L, Meng X, Dong X, Wang H, Yang R, Mei Q, Liu B, Yang L, Sun Y. Ficonalkib (SY-3505) in Advanced ALK-Positive NSCLC: A Multicenter, Open-Label, Single-Arm, Phase 1/2 Study. J Thorac Oncol. 2024 Jun;19(6):898-911. doi: 10.1016/j.jtho.2024.01.015. Epub 2024 Jan 29.
PubMed 38295954

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Antitumor Activity of SY-3505 Capsule in Patients With ALK-positive Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05257512
Acronym / sponsor ID: SY-3505-I
Conditions: Non-small Cell Lung Cancer
Keywords: SY-3505, ALK, NSCLC
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Shouyao Holdings (Beijing) Co. LTDUniversity, hospital or other
Study start: 26 Apr 2020 (actual)
Primary completion: 26 Apr 2024 (estimated)
Study completion: 26 Aug 2024 (estimated)
First posted: 25 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 a phase I/II, open-label and multi-center study of SY-3505, a third-generation ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer (ALK-positive NSCLC).

Detailed description

The study consists of two parts:

Part 1: Dose-escalation and dose-expansion in patients with advanced ALK-positive NSCLC, including 9 SY-3505 dose levels.

Part 2: Phase 2 study to evaluate the efficacy of SY-3505.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Phase I/II Study of SY-3505	Experimental	Drug: SY-3505SY-3505 will be given orally in ascending doses (escalation cohort), until the DLT or RP2D is reached. Up to 6 patients will then be enrolled in the expansion cohort at the recommended dose. In phase II, SY-3505 will be given at RP2D in advanced ALK-positive NSCLC patients.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Male or female, age ≥ 18 years at the time of screening.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Estimated Life expectancy ≥ 12 weeks.
Must have either at least one measurable lesion with no prior local treatment or measurable lesions with definite progression (Bone metastases alone were not accepted) after local treatment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Dose-escalation phase: patients must have histological or cytological confirmed ALK-positive advanced NSCLC. Dose-expansion phase: patients must have histological or cytological confirmed ALK-positive advanced NSCLC and progressed after at least one prior line of ALK TKI therapy. Phase II: patients must have histological or cytological confirmed ALK-positive advanced NSCLC and progressed after only alectinib or ≥2 prior ALK TKIs treatment. The pathological report requires either positivity for ALK gene expression determined by fluorescence in-situ hybridization (FISH) assay, immunohistochemistry (IHC), reverse transcription-polymerase chain reaction (RT-PCR), next-generation sequencing (NGS) or other identified methods from previous reports and provide tissue for ALK retest if possible or providing tissue for ALK test if no previous report is available.

Key exclusion criteria (17 listed)

Any of the following within 6 months prior to starting trial treatment: Cerebrovascular accident/ stroke, myocardial infarction, severe/ unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), second- or third- degree atrioventricular (AV) block (unless paced) or any AV block with PR interval >220 msec, or any grade of uncontrolled atrial fibrillation.
ECG evaluated QT interval corrected (Fridericia) (QTcF) of > 450 msec in males or > 470 msec in females or congenital long QT syndrome.
Grade ≥ 3 peripheral neuropathy (CTCAE version 5.0).
Any active autoimmune diseases or history of autoimmune diseases that require long-term steroid or other immunosuppressants treatment.
Previous medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.

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
SY-3505Also: CT-3505The third-generation ALK TKI	Drug	Phase I/II Study of SY-3505

Primary outcome

Phase I: Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment
Time frame: Dose-escalation Cycle 1 (each cycle is 28 days)
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) in Cycle 1.
Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 24 months
Characterization of the safety and tolerability
Phase II: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Time frame: Up to 24 months
Anti-tumor activity of SY-3505

11 secondary outcomes

Phase I: Overall Response Rate (ORR) as assessed by RECIST 1.1 criteria
Time frame: Up to 24 months
Phase I & II: Disease control rate (DCR) as assessed by RECIST 1.1 criteria
Time frame: Up to 24 months
Phase I & II: Duration of response (DOR)
Time frame: Up to 24 months
Phase I & II: Progression-free survival (PFS)
Time frame: Up to 24 months
Phase I & II: Overall survival (OS)
Time frame: Up to 24 months
Phase I & II: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 24 months
Phase I & II: Pharmacokinetics (Cmax) for SY-3505
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (Tmax) for SY-3505
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (AUC0-t) for SY-3505
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (t½) for SY-3505
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)
Phase I & II: Pharmacokinetics (Cl/F) for SY-3505
Time frame: Protocol-defined time points during Cycles 1 and 2 of treatment (each cycle is 28 days)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Derived from this study: PubMed 38295954Shi Y, Hu X, Li X, Gong C, Wang K, Li Y, Zhang S, Luo Y, Wang P, Jiang L, Meng X, Dong X, Wang H, Yang R, Mei Q, Liu B, Yang L, Sun Y. Ficonalkib (SY-3505) in Advanced ALK-Positive NSCLC: A Multicenter, Open-Label, Single-Arm, Phase 1/2 Study. J Thorac Oncol. 2024 Jun;19(6):898-911. doi: 10.1016/j.jtho.2024.01.015. Epub 2024 Jan 29.
Individual participant dataSharing planned: No

Related trials for 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
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
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

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.

Yinghui Sun, PhD contact

86-10-88858616

yhsun@centaurusbio.com

Yinghui Sun, PhD study director

Shouyao Holdings (Beijing) Co. LTD

1 site 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 SY-3505 in people with Non-small Cell Lung Cancer, run by Shouyao Holdings (Beijing) Co. LTD 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 24 inclusion and 17 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 14 Feb 2023. 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 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 Yinghui Sun, PhD (86-10-88858616, yhsun@centaurusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (time frame: Dose-escalation Cycle 1 (each cycle is 28 days)). 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 NCT05257512, 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 14 Feb 2023.