Metastatic Breast CancerPhase 1/2NCT06202261
A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer
A Phase 1/2 study testing TQB2930 for injection, Paclitaxel for injection (albumin-bound) and TQB3616 capsule in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Breast Cancer, Recurrent Breast Cancer, Advanced Malignancies
- What is being tested?
- TQB2930 for injection, Paclitaxel for injection (albumin-bound) and TQB3616 capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesChina
- Study dates
- 13 Apr 2023to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; The expected survival is over 3 months.
- Phase Ib
- Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
- Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
- Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria
- Phase II
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- Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology / histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:
- Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;
- at least one measurable lesion that meets the RECIST 1.1 criteria.
- Major organs are functioning normally.
- Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.
Who cannot join
- Have occured other malignant tumors within 3 years prior to first dose.
- Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
- Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
- Long-term unhealed wounds or fractures;
- Arterial/venous thrombosis events occurred within 6 months before the first dose;
- Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;
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- Subject with any severe and/or uncontrolled disease;
- Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;
- Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;
- Severe bone injury due to bone metastasis;
- Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;
- In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to <50% or absolute LVEF decreased >15%;
- Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes >360 mg/m2;
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy
- Patients with severe hypersensitivity after the use of monoclonal antibodies;
- Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Affiliated Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, 400000
Xiaohua Zeng, 13983687701, zengxiaohua000017@163.com
- Recruiting
Affiliated cancer hospital of harbin medical university
Harbin, Heilongjiang, 150001
Qingyuan Zhang, Doctor, +86 0451 86298070, sy86298276@163.com
About this study
Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).
- Being tested
- TQB2930 for injection, Paclitaxel for injection (albumin-bound), TQB3616 capsule, Fulvestrant injection, Capecitabine tablets
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2930 for injectionDrug
TQB2930 for injection is a HER2 bispecific antibody.
Paclitaxel for injection (albumin-bound)Drug
It is an anti-microtubule chemotherapy drug
TQB3616 capsuleDrug
TQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.
Fulvestrant injectionDrug
Fulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol
Capecitabine tabletsDrug
Capecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action.
Vinorelbine tartrate injectionDrug
Vinorelbine is an anti-tumor drug of vinca alkaloids.
Eribulin mesylate injectionDrug
Eribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism.
gemcitabine hydrochloride for injectionDrug
Gemcitabine is a cell cycle specific anti-metabolic anticancer agent
| Study group | Role | What they receive |
|---|---|---|
| TQB2930 for injection | Experimental | TQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle. Receives: Drug: TQB2930 for injection |
| TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound) | Experimental | TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle Receives: Drug: TQB2930 for injection; Drug: Paclitaxel for injection (albumin-bound) |
| TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection | Experimental | TQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle. Receives: Drug: TQB2930 for injection; Drug: TQB3616 capsule; Drug: Fulvestrant injection |
| TQB2930 for injection + chemotherapy | Experimental | TQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle. Receives: Drug: TQB2930 for injection; Drug: Capecitabine tablets; Drug: Vinorelbine tartrate injection; Drug: Eribulin mesylate injection; Drug: gemcitabine hydrochloride for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.
Measured: Baseline up to 4 months
Phase II recommended dose (P2RD)
Optimal tolerated dose determined after the end of phase 1
Measured: Baseline up to 1 year
Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit.
Measured: Baseline up to 2 year
Secondary outcomes (12)
Immunogenicity
Incidence of anti-drug antibody (ADA)
Measured: Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.
Peak concentration (Cmax), QW
The maximum serum concentration after administration
Measured: Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.
Peak concentration (Cmax), Q2W
The maximum serum concentration after administration
Measured: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.
Peak concentration (Cmax), Q3W
The maximum serum concentration after administration
Measured: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.
Overall survival (OS)
From randomization to the time of death from any cause.
Measured: Baseline up to 4 years
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: Baseline up to 2 years
Progression-free survival (PFS)
The time between the first medication and disease progression (PD) or death before PD.
Measured: Baseline up to 1 year
Disease control rate (DCR)
The ratio of disease control cases (partial remission, complete response, stable disease) to total cases.
Measured: Baseline up to 2 years
Duration of remission (DOR)
The time from the first evaluation of the tumor as a complete or partial response to the first evaluation as tumor progression or death.
Measured: Baseline up to 2 years
Clinical benefit rate (CBR)
The ratio of disease control cases (partial remission, complete response, stable disease ≥ 6 month) to total cases.
Measured: Baseline up to 2 years
Peak concentration (Cmax), arm 2
The maximum serum concentration after administration in arm 2
Measured: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 28 days.
Peak concentration (Cmax), arm 3 and 4
The maximum serum concentration after administration in arm 3 and 4.
Measured: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 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 Jan 2024
- Study start13 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202261
- Sponsor's protocol ID
- TQB2930-Ib/II-01
- Status last verified
- Mar 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent / Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06202261
- Acronym / sponsor ID
- TQB2930-Ib/II-01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Jan 2024 (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 Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TQB2930 for injection | Experimental | Drug: TQB2930 for injectionTQB2930 for injection,10 mg/kg, quaque week (QW), 21 day as a treatment cycle; TQB2930 for injection, 20 mg/kg, quaque 2 weeks (Q2W), 28 day as a treatment cycle; TQB2930 for injection,30 mg/kg, quaque 3 weeks (Q3W), 21 day as a treatment cycle. |
| TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound) | Experimental | Drug: TQB2930 for injection, Drug: Paclitaxel for injection (albumin-bound)TQB2930 for injection 30mg/kg combined with paclitaxel (albumin-bound) for injection, 21 days for one treatment cycle |
| TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection | Experimental | Drug: TQB2930 for injection, Drug: TQB3616 capsule, Drug: Fulvestrant injectionTQB2930 for injection 20mg/kg combined with TQB3616 capsule 120mg or 150mg or 180mg, and fulvestrant injection. Q2W, 28 days a cycle. |
| TQB2930 for injection + chemotherapy | Experimental | Drug: TQB2930 for injection, Drug: Capecitabine tablets, Drug: Vinorelbine tartrate injection, Drug: Eribulin mesylate injection, Drug: gemcitabine hydrochloride for injectionTQB2930 for injection 30mg/kg combined with capecitabine tablets or vinorelbine tartrate injection or eribulin mesylate injection or gemcitabine hydrochloride for injection, 21 days a cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; The expected survival is over 3 months.
- Phase Ib
- Phase II
- Major organs are functioning normally.
- Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy / urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.
Key exclusion criteria (16 listed)
- Have occured other malignant tumors within 3 years prior to first dose.
- Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
- Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
- Long-term unhealed wounds or fractures;
- Arterial/venous thrombosis events occurred within 6 months before the first dose;
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 |
|---|---|---|
| TQB2930 for injectionTQB2930 for injection is a HER2 bispecific antibody. | Drug | TQB2930 for injection, TQB2930 for injection + chemotherapy, TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound), TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection |
| Paclitaxel for injection (albumin-bound)It is an anti-microtubule chemotherapy drug | Drug | TQB2930 for injection 30mg/kg + Paclitaxel for injection (albumin-bound) |
| TQB3616 capsuleTQB3616 capsule is a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. | Drug | TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection |
| Fulvestrant injectionFulvestrant is a competitive estrogen receptor antagonist with similar affinity to estradiol | Drug | TQB2930 for injection+TQB3616 capsule for injection + fulvestrant injection |
| Capecitabine tabletsCapecitabine is converted to 5-fluorouracil (5-FU) by in vivo enzyme action. | Drug | TQB2930 for injection + chemotherapy |
| Vinorelbine tartrate injectionVinorelbine is an anti-tumor drug of vinca alkaloids. | Drug | TQB2930 for injection + chemotherapy |
| Eribulin mesylate injectionEribulin induces G2/M phase cell cycle arrest, mitotic spindle division, and ultimately apoptosis after prolonged mitotic arrest through its tubulin-based anti-mitotic mechanism. | Drug | TQB2930 for injection + chemotherapy |
| gemcitabine hydrochloride for injectionGemcitabine is a cell cycle specific anti-metabolic anticancer agent | Drug | TQB2930 for injection + chemotherapy |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 4 months
The highest dose when dose-limiting toxicity (DLT) occurs in less than 33% of subjects.
Phase II recommended dose (P2RD)
Time frame: Baseline up to 1 year
Optimal tolerated dose determined after the end of phase 1
Investigators assessed Objective remission rate (ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame: Baseline up to 2 year
The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit.
12 secondary outcomes
Immunogenicity
Time frame: Pre-dose on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, each cycle is 21 or 28 days.
Peak concentration (Cmax), QW
Time frame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 8, each cycle is 21 days.
Peak concentration (Cmax), Q2W
Time frame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 1 Day 15, Cycle 2 Day 15, each cycle is 28 days.
Peak concentration (Cmax), Q3W
Time frame: Pre-dose, 30 minuets, 4, 8, 24, 48, 72, 168, 240, 336 hours after dose on Cycle 1 Day 1, Cycle 2 Day 1; Pre-dose on Cycle 3 Day 1, each cycle is 21 days.
Overall survival (OS)
Time frame: Baseline up to 4 years
Adverse event rate
Time frame: Baseline up to 2 years
Progression-free survival (PFS)
Time frame: Baseline up to 1 year
Disease control rate (DCR)
Time frame: Baseline up to 2 years
Duration of remission (DOR)
Time frame: Baseline up to 2 years
Clinical benefit rate (CBR)
Time frame: Baseline up to 2 years
Peak concentration (Cmax), arm 2
Time frame: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 28 days.
Peak concentration (Cmax), arm 3 and 4
Time frame: Pre-dose, 30 minuets after dose of Cycle 1 Day 1,Cycle 2 Day 1, Cycle 4 Day 1,Cycle 7 Day 1,Cycle 12 Day 1,Cycle 17 Day 1. each cycle is 21 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
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 TQB2930 for injection, Paclitaxel for injection (albumin-bound) and TQB3616 capsule in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites 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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingyuan Zhang, Doctor (+86 0451 86298070, sy86298276@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Baseline up to 4 months). 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?
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 12 Mar 2024.