NeoplasmsPhase 1NCT06161558

Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors

A Phase 1 study testing Erlotinib, Lenvatinib and Axitinib in people with Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Neoplasms
What is being tested?: Erlotinib, Lenvatinib and Axitinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2025to 15 Jul 2025
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 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist.
Age >=18 years.
Patients must have evaluable disease according to RECIST 1.1 criteria.
ECOG performance status =< 2.
Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count >=1,500/mcL

Show all 26Show fewer

Platelets >=100,000/mcL
Total bilirubin <=1.5 X institutional ULN (with the exception of those with Gilbert syndrome, who must have total bilirubin <=3 X institutional ULN
AST(SGOT)/ALT(SGPT) <=3 X institutional upper limit of normal; <= 5.0 x ULN in patients with liver metastases
creatinine <=1.5 X institutional ULN
OR
creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels >1.5 mg/dL
Based on preclinical safety data and their respective mechanisms of action, erlotinib, lenvatinib, and axitinib can cause fetal harm when administered to pregnant women. For this reason, women of child-bearing potential and men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 1 month after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.
Patients with non-healing wounds/fistulas may enroll if no immediate surgical input is required in the opinion of the PI.
Patients must have <= 1+ proteinuria on urinalysis, or < 1 g protein on 24-hour urine collection, or a urine protein:creatinine ratio of < 1.
Prior anti-EGFR- and anti-VEGF/VEGFR-targeted therapy is permitted, provided that the patient has not undergone prior anti-EGFR/anti-VEGF(R) TKI combination therapy.
Patients must be able to swallow.
Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression.
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
Patients known to be positive for HIV who meet the following criteria will be considered eligible:
CD4 count > 350 cells/mm^3
Undetectable viral load for 6 months prior to enrollment
Maintained on modern therapeutic regimens utilizing non-CYP-interactive agents
No history of AIDS-defining opportunistic infections
Patients must be willing to provide blood for research purposes.

Who cannot join

For the erlotinib-lenvatinib arm only: patients with a QTcF interval of >=480 msec at study entry or with congenital long QT syndrome are excluded.
Patients who are receiving any investigational agents are excluded.
Patients who are receiving >2 anti-hypertensive agents will be excluded.
Patients who are receiving strong CYP3A4- and/or CYP1A2-inhibiting or -inducing agents that cannot be discontinued or replaced with an alternative medication will be excluded.
Patients who are receiving agents that increase gastric pH and that cannot be discontinued or replaced with an alternative medication will be excluded.
Patients who smoke tobacco will be excluded.

Show all 11Show fewer

Patients with a history of cirrhosis will be excluded if found to have a moderate or severe Child-Pugh score.
Patients should not, in the opinion of the Principal Investigator, have GI impairment that may limit the absorption of erlotinib, lenvatinib, or axitinib.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.
Uncontrolled intercurrent illness that would, in the opinion of the Principal Investigator, limit compliance with study requirements.
Pregnant and breastfeeding women are excluded from this study because all 3 study drugs can cause fetal harm, based on preclinical safety data and the respective drug mechanisms of action. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug, and women should refrain from nursing throughout the treatment period and for 1 month following the last dose of study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors

Cancers that return or spread after their first line of treatment are often difficult to treat with limited next step options. Based on preclinical studies, the EGFR-targeting tyrosine kinase inhibitor (TKI) Erlotinib may be better in stopping or slowing the growth of tumors when given in combination with the multitargeting TKI Lenvatinib or Axitinib. Participants will be screened with a physical exam and tests including urine and blood tests, imaging scans, and a test of their heart function. Erlotinib, axitinib, and lenvatinib are all capsules taken by mouth. All participants will take their drugs at home every day. Some participants will take erlotinib plus lenvatinib once a day. Some participants will take erlotinib once a day and axitinib twice a day. Assignment to one of the treatment arms will be determined by the study. Participants will record their doses in a diary. Treatment is given in 28-day cycles. All participants will have 4 clinic visits during their first treatment cycle. After that, they will have a clinic visit at the start of each new cycle. Imaging scans, blood and urine tests, and other tests will be repeated during various clinic visits. Participants will remain in the study for as long as the treatment is helping them. They will have follow-up phone calls after they stop treatment....

Read the detailed description

Primary Objective:

-To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors

Secondary Objective:

-To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination

Exploratory Objectives:

To assess the preliminary antitumor activity of the erlotinib-lenvatinib and erlotinib-axitinib combinations in patients with advanced solid tumors
To examine changes in numbers of circulating tumor cells (CTCs) of epithelial (cytokeratin+) or mesenchymal (vimentin+) phenotype in response to the erlotinib-lenvatinib or erlotinib-axitinib combinations
To examine genomic alterations in circulating tumor DNA (ctDNA) that may be associated with response or resistance to the erlotinib-lenvatinib or erlotinib-axitinib combination

Study Design:

This is an open-label, 2-arm phase 1 trial.
All agents will be administered orally in 28-day cycles. Dose escalation on both arms will follow a 3 plus 3 design, with intrapatient dose escalation permitted.
Assignment to one of the treatment arms will be determined by the study.
The study will allow accrual of patients to backfill cohorts, in which patients will be enrolled on the most recently cleared dose level when accrual to the current dose level has been completed per 3 plus 3 design, but the DLT monitoring period has yet to be completed at that dose level. Dose-limiting toxicities will be defined during the first cycle of treatment.
The accrual ceiling will be set at 70 patients.

Conditions: Neoplasms
Being tested: Erlotinib, Lenvatinib, Axitinib
Keywords: Kinase Inhibitor, Combination, Pharmacodynamic, TKI
Medical subject headings: Neoplasms

What participants receive

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

ErlotinibDrug
Small-molecule tyrosine kinase inhibitor targeting EGFR
LenvatinibDrug
Small-molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3
AxitinibDrug
Small-molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3

Study groups in NCT06161558
Study group	Role	What they receive
A	Experimental	Erlotinib with lenvatinib combination Receives: Drug: Erlotinib; Drug: Lenvatinib
B	Experimental	Erlotinib with axitinib combination Receives: Drug: Erlotinib; Drug: Axitinib

What is being measured

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

To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
This is an open-label phase 1 umbrella trial with 2 treatment arms. All agents will be administered orally in 28-day cycles. The starting dose level (DL) will be DL 1A for Arm A (the erlotinib-lenvatinib combination arm) and DL 1B for Arm B (the erlotinib-axitinib combination arm). Dose escalation on both arms will follow a 3+3 design. Intrapatient dose escalation to the next highest cleared dose level will be permitted upon completion of >= 1 cycle of therapy at the current dose level at which the patient is being treated. Dose-limiting toxicities will be defined during the first cycle of treatment. Patients will be assigned to one of the two treatment arms in an alternating fashion.
Measured: 30 months

Secondary outcomes (1)

To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination
Mandatory blood specimens for pharmacokinetic (PK) analysis will be collected aseptically by venipuncture or an existing venous port at baseline and several on-treatment timepoints. Samples will be analyzed using a validated LC-MS/MS method in human plasma.
Measured: 30 months

Timeline

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

15 Jul 202515 Jul 2025

First posted8 Dec 2023
Study start15 Jul 2025
Primary completion15 Jul 2025
Study completion15 Jul 2025

Why it stopped: Lack of resources to complete study objectives. No participants enrolled.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for NeoplasmsStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06161558
Sponsor's protocol ID: 10001657
Other IDs: 001657-C
Status last verified: Jul 2025
First submitted: 7 Dec 2023
Last updated: 16 Jul 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.

Publications

Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29.
PubMed 21031001
Conradt L, Godl K, Schaab C, Tebbe A, Eser S, Diersch S, Michalski CW, Kleeff J, Schnieke A, Schmid RM, Saur D, Schneider G. Disclosure of erlotinib as a multikinase inhibitor in pancreatic ductal adenocarcinoma. Neoplasia. 2011 Nov;13(11):1026-34. doi: 10.1593/neo.111016.
PubMed 22131878
Augustin A, Lamerz J, Meistermann H, Golling S, Scheiblich S, Hermann JC, Duchateau-Nguyen G, Tzouros M, Avila DW, Langen H, Essioux L, Klughammer B. Quantitative chemical proteomics profiling differentiates erlotinib from gefitinib in EGFR wild-type non-small cell lung carcinoma cell lines. Mol Cancer Ther. 2013 Apr;12(4):520-9. doi: 10.1158/1535-7163.MCT-12-0880. Epub 2013 Jan 31.
PubMed 23371860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

All Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 Umbrella Trial of Erlotinib In Combination With Select Tyrosine Kinase Inhibitors In Adult Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06161558
Acronym / sponsor ID: 10001657
Conditions: Neoplasms
Keywords: Kinase Inhibitor, Combination, Pharmacodynamic, TKI
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Lack of resources to complete study objectives. No participants enrolled.
Enrolment: 0 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 15 Jul 2025 (actual)
Primary completion: 15 Jul 2025 (actual)
Study completion: 15 Jul 2025 (actual)
First posted: 8 Dec 2023 (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.

Detailed description

Primary Objective:

-To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors

Secondary Objective:

-To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination

Exploratory Objectives:

To assess the preliminary antitumor activity of the erlotinib-lenvatinib and erlotinib-axitinib combinations in patients with advanced solid tumors
To examine changes in numbers of circulating tumor cells (CTCs) of epithelial (cytokeratin+) or mesenchymal (vimentin+) phenotype in response to the erlotinib-lenvatinib or erlotinib-axitinib combinations
To examine genomic alterations in circulating tumor DNA (ctDNA) that may be associated with response or resistance to the erlotinib-lenvatinib or erlotinib-axitinib combination

Study Design:

This is an open-label, 2-arm phase 1 trial.
All agents will be administered orally in 28-day cycles. Dose escalation on both arms will follow a 3 plus 3 design, with intrapatient dose escalation permitted.
Assignment to one of the treatment arms will be determined by the study.
The study will allow accrual of patients to backfill cohorts, in which patients will be enrolled on the most recently cleared dose level when accrual to the current dose level has been completed per 3 plus 3 design, but the DLT monitoring period has yet to be completed at that dose level. Dose-limiting toxicities will be defined during the first cycle of treatment.
The accrual ceiling will be set at 70 patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Erlotinib, Drug: LenvatinibErlotinib with lenvatinib combination
B	Experimental	Drug: Erlotinib, Drug: AxitinibErlotinib with axitinib combination

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Patients must have histologically confirmed solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist.
Age >=18 years.
Patients must have evaluable disease according to RECIST 1.1 criteria.
ECOG performance status =< 2.
Patients must have normal organ and marrow function as defined below:

Key exclusion criteria (11 listed)

For the erlotinib-lenvatinib arm only: patients with a QTcF interval of >=480 msec at study entry or with congenital long QT syndrome are excluded.
Patients who are receiving any investigational agents are excluded.
Patients who are receiving >2 anti-hypertensive agents will be excluded.
Patients who are receiving strong CYP3A4- and/or CYP1A2-inhibiting or -inducing agents that cannot be discontinued or replaced with an alternative medication will be excluded.
Patients who are receiving agents that increase gastric pH and that cannot be discontinued or replaced with an alternative medication will be excluded.

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
ErlotinibSmall-molecule tyrosine kinase inhibitor targeting EGFR	Drug	A, B
LenvatinibSmall-molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3	Drug	A
AxitinibSmall-molecule tyrosine kinase inhibitor targeting VEGFR1, VEGFR2, and VEGFR3	Drug	B

Primary outcome

To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors
Time frame: 30 months
This is an open-label phase 1 umbrella trial with 2 treatment arms. All agents will be administered orally in 28-day cycles. The starting dose level (DL) will be DL 1A for Arm A (the erlotinib-lenvatinib combination arm) and DL 1B for Arm B (the erlotinib-axitinib combination arm). Dose escalation on both arms will follow a 3+3 design. Intrapatient dose escalation to the next highest cleared dose level will be permitted upon completion of >= 1 cycle of therapy at the current dose level at which the patient is being treated. Dose-limiting toxicities will be defined during the first cycle of treatment. Patients will be assigned to one of the two treatment arms in an alternating fashion.

1 secondary outcome

To evaluate the plasma pharmacokinetic profiles of erlotinib and either lenvatinib or axitinib when used in combination
Time frame: 30 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Background: PubMed 21031001Kummar S, Chen HX, Wright J, Holbeck S, Millin MD, Tomaszewski J, Zweibel J, Collins J, Doroshow JH. Utilizing targeted cancer therapeutic agents in combination: novel approaches and urgent requirements. Nat Rev Drug Discov. 2010 Nov;9(11):843-56. doi: 10.1038/nrd3216. Epub 2010 Oct 29.
Background: PubMed 22131878Conradt L, Godl K, Schaab C, Tebbe A, Eser S, Diersch S, Michalski CW, Kleeff J, Schnieke A, Schmid RM, Saur D, Schneider G. Disclosure of erlotinib as a multikinase inhibitor in pancreatic ductal adenocarcinoma. Neoplasia. 2011 Nov;13(11):1026-34. doi: 10.1593/neo.111016.
Background: PubMed 23371860Augustin A, Lamerz J, Meistermann H, Golling S, Scheiblich S, Hermann JC, Duchateau-Nguyen G, Tzouros M, Avila DW, Langen H, Essioux L, Klughammer B. Quantitative chemical proteomics profiling differentiates erlotinib from gefitinib in EGFR wild-type non-small cell lung carcinoma cell lines. Mol Cancer Ther. 2013 Apr;12(4):520-9. doi: 10.1158/1535-7163.MCT-12-0880. Epub 2013 Jan 31.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.

Related trials for Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian 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.

Sarah J Shin, M.D. principal investigator

National Cancer Institute (NCI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erlotinib, Lenvatinib and Axitinib in people with Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.

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 26 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 Jul 2025. 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 United States. 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 withdrawn before enrolling participants, so there are no results.

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?

To establish the safety, tolerability, and maximum tolerated dose (MTD) of the erlotinib-lenvatinib and erlotinib-axitinib combinations in adult patients with advanced solid tumors (time frame: 30 months). 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 NCT06161558, which also lists 3 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 16 Jul 2025.