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PDAC - Pancreatic Ductal AdenocarcinomaPhase 2PANORAMIXNCT07028424

PANORAMIX : Optimizing 1st-line NALIRIFOX and Exploring Microbiota's Role in 2nd Line Pancreatic Cancer Treatment

A Phase 2 study testing Nal-IRI, Ciprofloxacin and Paclitaxel in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 12 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PDAC - Pancreatic Ductal Adenocarcinoma
What is being tested?
Nal-IRI, Ciprofloxacin and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
12 sitesFrance
Study dates
Jul 2025to Dec 2030
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Overlapping inclusion criteria for STEP 1 AND STEP 2
  • Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations (only after interim analysis at Step 2 for patients who were not randomized in first randomization [R1]),
  • Age ≥18 years old. STEP 1: The patient over 75 years of age is eligible only if the patient's G8 score (G8 questionnaire) is > 14,
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1,
  • Histologically or cytologically proven PDAC,
  • ≥1 measurable lesion according to RECIST v 1.1 (Computed tomography thorax-abdomen-pelvis [TAP-CT] scan ≤ 4 weeks), Note: abdominal magnetic resonance imaging (MRI) is allowed (e.g., in case of contra-indication to CT scan contrast injection) provided that this imaging modality is used consistently throughout the tumor evaluations,
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  • Availability of archival tissue samples for exploratory research. Step 2: can be the same as in Step 1 or it can be newly obtained sample,
  • Adequate organ function, obtained within 21 days prior to randomization of study treatment, as defined by the following:
  • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN; ≤ 5 x ULN in case of liver metastases) - STEP 2, if paclitaxel administration,
  • Total serum bilirubin < 1.5 x ULN (STEP 2, if paclitaxel administration),
  • Serum albumin ≥ 28 g/L,
  • Hemoglobin ≥ 9.0 g/dl,
  • Absolute neutrophil count (ANC) ≥ 2 x 10^9L,
  • Platelets - STEP 1: ≥ 150 x 10^9L; STEP 2: ≥ 100 x 10^9L,
  • Creatinine clearance ≥ 50 mL/min (Modification of the Diet in Renal Disease [MDRD]),
  • Evidence of post-menopausal status or negative serum pregnancy test within 7 days before starting study treatment for female pre- menopausal patients. Women of childbearing potential (WOCBP) should use effective contraception during study treatment and: 1 month (paclitaxel), 6 months (5FU, LV), 7 months (NAL-IRI), 15 months (oxaliplatin), and 6 months (gemcitabine+/-paclitaxel and ciprofloxacin/placebo) after the patient's last dose of treatment. Males who are fertile should use effective contraception during study treatment and 4 months (NAL-IRI), 6 months (5-FU, LV), 12 months (oxaliplatin), and 6 months (gemcitabine+/-paclitaxel and ciprofloxacin/placebo) after the patient's last dose of treatment.
  • Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up,
  • Registration in a National Health Care System (PUMa - Protection Universelle Maladie included).
  • Distinct inclusion criteria for STEP 1 and STEP 2 STEP 1
  • No prior first-line chemotherapy (5-FU or gemcitabine based, or FOLFIRINOX) for metastatic disease; if treatment with any investigational medicinal product (IMP) the delay before the last dose and inclusion more than or equal to 28 days, Note: relapse after FOLFIRINOX adjuvant chemotherapy in case of resectable disease is NOT allowed,
  • No dihydropyrimidine dehydrogenase (DPD) deficiency (Uracilemia dosage >16 ng/ml), Uracilemia dosing results must be available before inclusion).
  • STEP 2 11. Metastatic disease, 12. L2 therapy after progression under 5-FU-based chemotherapy for localized/locally advanced or metastatic stage, Note: relapse <4 months after the end of adjuvant chemotherapy in case of resectable disease is allowed.

Who cannot join

  • Overlapping exclusion criteria for STEP 1 AND STEP 2
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study,
  • History of allogenic organ transplantation or active autoimmune, connective tissue disorder, or inflammatory disease requiring systemic treatment,
  • Diagnosis of any second malignancy that required any treatment within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri,
  • History of idiopathic pulmonary fibrosis, interstitial lung disease (ILD), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening (TAP-CT-scan),
  • Current systemic steroid therapy (>10 mg daily dose of prednisone or equivalent; minimal wash-out of 1 week [7 days]) or immunosuppressive therapy,
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  • Prior radiotherapy treatment to more than 30% of the bone marrow or a wide field of radiation within 4 weeks (30 days) prior to the first dose of study drug,
  • Major surgical procedure (as defined by the Investigator) within 4 weeks (30 days) prior to the first dose of trial treatment (Step 1 and Step 2), Note: Local surgery of isolated lesions for palliative intent is acceptable,
  • Uncontrolled central nervous system metastases and/or carcinomatous meningitis,
  • Uncontrolled massive pleural effusion or massive ascites,
  • Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure or coronary disease, peripheral artery disease, severe chronic obstructive pulmonary disease, decompensated cirrhosis, serious chronic gastrointestinal conditions (e.g. bleeding, inflammation, occlusion, malabsorption syndrome, ulcerative colitis, gastrointestinal ulceration, infection or sepsis, inflammatory bowel disease or partial bowel obstruction) associated with diarrhea, or geographical/social/ psychiatric illness situations that would limit compliance with study requirement and study follow-up, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent,
  • History or current evidence of any condition, therapy, laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant in the opinion of the treating investigator,
  • QT/QTc interval >470 ms (for women) and > 450 ms (for men), previous ventricular arrhythmia, known or suspected long-QT syndrome, Note: Caution is required when using medicinal products with human thymidine kinase substrates, e.g. zidovudine and other drugs known to prolong the QTc interval (exhaustive list on https: //www.crediblemeds.org.")
  • Known or suspected allergy or hypersensitivity to any of the study drugs or any of the study drug excipients,
  • Active bacterial, viral, or fungal infection requiring systemic therapy, including tuberculosis, hepatitis B (HBV, known positive HBV surface antigen [HbsAg] result), hepatitis C (HBC, with positive RNA), or human immunodeficiency virus (HIV positive 1/2 antibodies), Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HbsAg test and a positive hepatitis B core antigen [HBc] antibody test) are eligible; patients with previously treated and cured HCV infection (negative RNA) are also eligible,
  • Live vaccine administration within 4 weeks (30 days) prior to the first dose of study treatment,
  • Pregnancy/breast-feeding/lactation,
  • Under a legal protection measure (guardianship, curatorship, or judicial safeguard), administrative decision, and/or incapable of giving his/her consent.
  • Distinct exclusion criteria for STEP 1 and STEP 2 STEP1 18. Any unresolved NCI CTCAE toxicity of grade ≥ 2 from previous anticancer therapy (including peripheral neuropathy of grade ≥ 1) except for alopecia or vitiligo, 19. Any previous chemotherapy for advanced disease, 20. Uncontrolled central nervous system metastases and/or carcinomatous meningitis, 21. Peripheral neuropathy with functional discomfort > grade 2, 22. Clinically significant active heart disease or myocardial infarction within 6 months given the cardiotoxicity of 5-FU, 23. Abnormal values of potassium, magnesium, and calcium levels at inclusion, 24. Patients with known homozygous UGT1A128 (Gilbert's disease), 25. Any use of strong CYP3A4 inducers/inhibitors and/or strong UGT1A1 inhibitors (patients are ineligible if unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving first dose of NAL-IRI injection), or presence of any other contraindications for irinotecan), 26. Brivudine-based treatment within 4 weeks preceding treatment initiation. STEP 2 18. Antibiotics use in the month before the day of treatment initiation or for > 5 days within 3 months before the day of treatment initiation, 19. Previous gemcitabine-based chemotherapy, 20. Known previous colonization or infection with K. pneumoniae resistant to quinolones, 21. Prophylactic phenytoin within 1 week (7 days) prior to the first dose of study treatment, 22. Any contra-indication to ciprofloxacin: history of fluoroquinolone-related severe side effects (muscle, tendons, joint…), severe aortic disease (aneurysm, dissection), myasthenia, epilepsy, 23. Inability to take oral treatment, 24. Concomitant medication with CYP1A2 substrates (e.g., theophylline, clozapine, duloxetine, tizanidine, olanzapine, propranolol, amitryptilin, and methotrexate, 25. Known glucose-6-phosphate dehydrogenase deficiency.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cindy NEUZILLET, MD contact

+33 (0) 1 47 11 15 15 ext. 7129

cindy.neuzillet@curie.fr

Marie-Line GARCIA LARNICOL, MD contact

+33 (0) 1 40 29 85 04

marie-line.garcia-larnicol@gercor.com.fr

12 sites in 1 country

France12 sites

  • CHU de Besançon

    Besançon

  • CHU de Grenoble

    La Tronche

  • CHU de Lille

    Lille

    Anthony TURPIN, MD

  • Institut Curie

    Paris

    Pauline VAFLARD, MD

  • Pitié Salpêtrière Hospital

    Paris

    Jean Baptiste BACHET, MD

  • Saint-Antoine Hospital

    Paris

  • CHU de Poitiers

    Poitiers

    David TOUGERON, MD

  • CHU de Reims

    Reims

    Olivier BOUCHE

  • Institute Curie

    Saint-Cloud

    Cindy NEUZILLET, MD

  • CHU de Saint Etienne

    Saint-Etienne

    Nicole WILLIET, MD

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé

    Julie LAVOLE, MD

  • Paul Brousse Hospital

    Villejuif

    Elise COLLE, MD

Other trials in France

About this study

Official title: Pancreatic Cancer First-line NALIRIFOX Optimization With 5-FU Maintenance and Role of Antibiotics and Microbiota Exploration in Second-line Treatment - A Non-comparative, Randomized Phase II PANORAMIX GERCOR G-116 PRODIGE 105 Study.

The main objective of PANORAMIX phase II trial is to optimize first-lie (L1) NALIRIFOX treatment for pancreatic cancer through the implementation of 5-fluorouracil (5-FU) maintenance therapy. Additionally, it aims to investigate the role of antibiotics and microbiota in second-line (L2) treatment.

Read the detailed description

This randomized non-comparative phase II study consists of two sequential steps.

Step 1 (main objective), the primary goal is to assess the efficacy of a maintenance strategy with LV5FU2 alone after disease control with first-line NALIRIFOX-based chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

Step 2 of the study (exploratory objective), aim is to assess the efficacy and safety of the addition of fluoroquinolone (ciprofloxacin) to gemcitabine-based chemotherapy in second-line setting.

Being tested
Nal-IRI, Ciprofloxacin, Paclitaxel, Gemcitabine, Oxaliplatin

What participants receive

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

  • Nal-IRIDrug

    Also called iposomal irinotecan

    NAL-IRI 50 mg/m2, administered over 80-100 minutes, on day 1 of a 14-days cycle

  • CiprofloxacinDrug

    6 capsules/cycle : 500 mg twice daily on days 1, 8, 15 (on day of gemcitabine infusion) for a maximum of 6 months

  • PaclitaxelDrug

    80 mg/m2 weekly on days 1, 8, 15 of each 28-days cycle (at the discretion of investigator)

  • GemcitabineDrug

    1,000 mg/m2 intravenously (IV) over 30 minutes weekly on days 1, 8, 15 of each 28-days cycle

  • OxaliplatinDrug

    60 mg/m2 (starting 2 hours later, administered over 110-130 minutes) on day 1

  • LeucovorinDrug

    As part of NALIRIFOX -for 8 cycle treatment: (L + D racemic form) 400 mg/m2 on day 1 (equivalent to 200 mg/m2 levoleucovorin) (starting 30 minutes after oxaliplatin, administered over 25-35 minutes)

    As part of LV5FU2 maintenance treatment: 400 mg/m2 IV infusion over 30 min on day 1 (equivalent to 200 mg/m2 levoleucovorin). LV could be administered over 2 hours to oxaliplatin according to The National Thesaurus of Digestive Oncology (TNCD) https://www.snfge.org/sites/www.snfge.org/files/tncd/2024-05/tncd_chap-09-cancer-pancre%CC%81as_2024-05-17_1.pdf, at investigator's discretion

  • 5-FluorouracilDrug

    As part of NALIRIFOX -for 8 cycle treatment: 2400 mg/m² IV initiated on day 1, with continuous infusion over 46 hours (no bolus infusion with 5-FU)

    As part of LV5FU2 maintenance treatment: 400 mg/m2 bolus over 10 min then 2,400 mg/m2 IV infusion over 46h

  • PlaceboOther

    6 capsules/cycle : 500 mg twice daily (morning and evening; 12 hours should elapse between two doses) on days 1, 8, 15 (on day of gemcitabine infusion) for a maximum of 6 months

Study groups in NCT07028424
Study groupRoleWhat they receive
STEP 1 - Experimental Arm 1A : First-line NALIRIFOX with LV5FU2 [5-FU/leucovorin] maintenance)ExperimentalNALIRIFOX (NAL-IRI + 5FU/LV + oxaliplatin; 8 cycles) followed by LV5FU2 maintenance administered every 14 days (2 weeks) followed by NALIRIFOX reintroduction (for maximum 8 cycles) followed by LV5FU2 maintenance
Receives: Drug: Nal-IRI; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil
STEP 1 - Arm 1B: NALIRIFOXActive comparatorNALIRIFOX until disease progression or unacceptable toxicity
Receives: Drug: Nal-IRI; Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-Fluorouracil
STEP 2 - Arm 2A: Gemcitabine +/- paclitaxel + ciprofloxacinExperimentalGemcitabine: 1,000 mg/m2 intravenously (IV) over 30 minutes weekly on days 1, 8, 15 of each 28-days cycle. +/- Paclitaxel 80 mg/m2 weekly on days 1, 8, 15 of each 28-days cycle (at the discretion of investigator). Ciprofloxacin (6 capsules/cycle, withhold if gemcitabine is not administered): 500 mg twice daily (morning and evening; 12 hours should elapse between two doses) on days 1, 8, 15 (on day of gemcitabine infusion) for a maximum of 6 months.
Receives: Drug: Ciprofloxacin; Drug: Paclitaxel; Drug: Gemcitabine
STEP 2 - Arm 2B: Gemcitabine +/- paclitaxel + placeboActive comparatorGemcitabine: 1,000 mg/m2 intravenously (IV) over 30 minutes weekly on days 1, 8, 15 of each 28-days cycle. +/- Paclitaxel 80 mg/m2 weekly on days 1, 8, 15 of each 28-days cycle (at the discretion of investigator). Placebo (6 capsules/cycle, withhold if gemcitabine is not administered): 500 mg twice daily (morning and evening; 12 hours should elapse between two doses) on days 1, 8, 15 (on day of gemcitabine infusion) for a maximum of 6 months.
Receives: Drug: Paclitaxel; Drug: Gemcitabine; Other: Placebo

What is being measured

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

  1. 6-month progression-free survival (PFS) rate post randomization Step 1 (R1) in Arm 1A

    To assess the efficacy of a 6-month PFS rate post R1 in patients with metastatic PDAC who received first-line (L1) NALIRIFOX with LV5FU2 (5-FU/leucovorin) maintenance strategy during Step 1 (Arm 1A).

    Measured: 6 months

Secondary outcomes (13)

  1. Progression-free survival first-line (PFS-L1) post randomization Step 1 (R1) in Arm 1A and in Arm 1B

    To assess PFS-L1 post R1 in Arm 1A and Arm 1B

    Measured: up to 5 years

  2. Progression-free survival (PFS) post NALIRIFOX reintroduction (PFS-reintro) in Arm 1A

    To assess PFS-reintro in Arm 1A

    Measured: up to 5 years

  3. Overall survival post randomization Step 1 (OS-R1) in Arm 1A and in Arm 1B

    To assess OS-R1 in Arm 1A and Arm 1B

    Measured: up to 5 years

  4. Overall response rate of first-line (ORR-L1) at 4 months in Arm 1A and in Arm 1B

    To assess ORR-L1 at 4 months in Arm 1A and Arm 1B, according to RECIST 1.1

    Measured: 4 months

  5. Overall response rate post NALIRIFOX reintroduction (ORR-RI) in Arm 1A

    To assess ORR-RI in Arm 1A

    Measured: up to 5 years

  6. Best response rate of first-line (BRR-L1) in Arm 1A and in Arm 1B

    To assess BRR-L1 in Arm 1A and Arm 1B

    Measured: up to 5 years

  7. Best response rate of first-line after reintroduction of NALIRIFOX (BRR-L1R) in Arm 1A

    To assess BRR-L1R in Arm 1A

    Measured: up to 5 years

  8. Duration of disease control (DDC) in Arm 1A and in Arm 1B

    To assess DDC in Arm 1A and in Arm 1B

    Measured: up to 5 years

  9. Grade 3-4 adverse events (AEs)/serious AEs (SAEs) related to treatment

    To assess safety (only grade 3-4 AEs/SAEs related to treatment in Arm 1A and Arm 1B, according to the NCI CTCAE v5.0

    Measured: until 28 days after end of treatment visit

  10. Rate of peripheral neuropathy in Arm 1A and Arm 1B

    To assess the rate of peripheral neuropathy (all grade and severe [grade 3-5] adverse events [AEs] in Arm 1A and Arm 1B, according to NCI CTCAE v5.0

    Measured: up to 5 years

  11. Health-related quality of life (HRQoL) by EORTC QLQ-C3 in Arm 1A and in Arm 1B

    To assess HRQoL in Arm 1A and Arm 1B using EORTC QLQ-C30 questionnaire.

    The EORTC QLQ-C30 is a 30-item, tumor-specific, patient-based questionnaire designed for self-administration. The form scores range from 0 to 100. Higher scores indicated worse symptomatic problems.

    Measured: up to 5 years

  12. Health-related quality of life (HRQoL) by EORTC QLQ-PAN26 in Arm 1A and in Arm 1B

    To assess HRQoL in Arm 1A and Arm 1B using EORTC QLQ-PAN26 questionnaire.

    The EORTC QLQ-PAN26 is a module specific to pancreatic cancer, to be used in conjunction to the EORTC QLQ-C30. It contains 26 items. As for the EORTC QLQ-C30, one score is generated for each item, in order that a high score represents a high functional level and a high symptomatic level. Estimated duration: 10 min.

    Measured: up to 5 years

  13. 6-month progression-free survival (PFS) post randomization (R1) of standard NALIRIFOX in Arm 1B

    To assess a 6-month PFS post R1 of standard NALIRIFOX in Arm 1B

    Measured: 6 months

Timeline

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

  1. First posted19 Jun 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized, non-comparative two-step study in patients with metastatic PDAC. STEP 1 (main objective) This is a two-arm, open-label, randomized (2:1), non-comparative single stage phase II study to assess the efficacy of 5-FU-based maintenance after NALIRIFOX initiation (Arm 1A) versus standard NALIRIFOX in patients with metastatic PDAC (Arm 1B). STEP 2 (secondary exploratory objective) This is a two-arm, double-blinded, randomized (1:1), non-comparative, two-stage phase II with ciprofloxacin + gemcitabine-based chemotherapy (gemcitabine +/- paclitaxel) regimen (Arm 2A) versus gemcitabine-based chemotherapy (gemcitabine +/- paclitaxel) regimen + placebo (Arm 2B)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
206 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07028424
Sponsor's protocol ID
PANORAMIX G-116 PRODIGE 105
Acronym
PANORAMIX
Status last verified
Jun 2025
First submitted
11 Jun 2025
Last updated
1 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nal-IRI, Ciprofloxacin and Paclitaxel in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 12 sites in France.

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 22 inclusion and 19 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: opening soon, as of the sponsor's last update on 1 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 12 sites in France. 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 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 Cindy NEUZILLET, MD (+33 (0) 1 47 11 15 15 ext. 7129, cindy.neuzillet@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month progression-free survival (PFS) rate post randomization Step 1 (R1) in Arm 1A (time frame: 6 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 NCT07028424.

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 1 Jul 2025.

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