Advanced Malignant Solid NeoplasmPhase 1/2NCT05039632
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
A Phase 1/2 study testing Hafnium Oxide-containing Nanoparticles NBTXR3 and Radiation Therapy in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung
- What is being tested?
- Hafnium Oxide-containing Nanoparticles NBTXR3 and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 1 Feb 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with metastatic disease in the lung and/or liver, or soft tissue from any primary malignancy considered incurable by local therapies.
- One prior anti-PD-1/L1 therapy allowed.
- The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable.
- Participant must have at least 2 measurable lesions at screening. i. Abscopal cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) (non-treated target lesion) will be followed for response and it will not receive NBTXR3 or RT.
- RadScopal™ cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) will only receive low dose radiation (low dose target lesion).
- Amenable to undergo the image guided (EBUS or CT or MRI) intratumoral injection of NBTXR3, in up to two (2) high dose target lesions, as determined by the investigator or treating physician at screening.
Show all 53Show fewer
- Intratumoral NBTXR3 injections only allowed in lung or liver lesions.
- Selected high and low dose target lesions must be amenable to receive radiation therapy as determined by the investigator or treating radiation oncologist.
- Allowed high dose RT regimens are 50 Gy in 4 fractions or 60 Gy in 10 fractions
- Allowed low dose RT for RadScopal™ cohort is 1.4 Gy per fraction for 4 - 5 fractions to only low dose-target lesion(s) determined by the investigator or treating physician.
- Patients can receive radiation therapy for symptomatic metastatic disease prior to enrollment or during the study a.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Laboratory Values at screening:
- Hemoglobin ≥ 9.0 g/dL
- Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Leukocytes ≥ 1500/mm3
- Creatinine ≤ 1.5 x upper limit of normal (ULN)
- Calc. creatinine clearance > 30mL/min
- Total bilirubin ≤ 2.0 mg/dL
- AST / ALT ≤ 2.0 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with liver metastases
- For participants to be treated for lung metastases, adequate lung function with expiratory volume in 1 second (FEV1) ≥ 0.8L or ≥ 35% predicted and carbon monoxide diffusing capability (DLCO) ≥ 40% with or without bronchodilator within 30 days prior to NBTXR3 injection. Participants to be treated for liver metastasis a pulmonary function test is not required.
- Patients who meet the criterion above without oxygen (02), but need acute (started within 7 ± 3 days) supplemental oxygen due to tumor-caused obstruction/hypoxia are eligible, provided the amount of the O2 needed has been stable.
- Negative urine or serum pregnancy test ≤ 7 days prior to NBTXR3 injection in all women of child-bearing potential (WOCBP). WOCBP must agree to follow instructions for method(s) of contraception for the duration the entire study period and 160 days (~5.33 months) after the last dose of anti-PD-1/L-1 treatment. Local laws and regulations may require use of alternative and/or additional contraception methods. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but should still undergo pregnancy testing.
- Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- 4.2 Exclusion criteria:
- Prior radiation therapy received to the selected high dose target lesion(s)
- Previous radiation to low dose target lesions allowed as per investigator or treating radiation oncologist discretion.
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Participants with previously treated brain metastases may participate if those lesions are radiologically stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging at screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to NBTXR3 injection.
- At screening, past medical history of:
- Interstitial lung disease
- Unresolved organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)
- Any Grade 4 radiation toxicity
- Unresolved, radiation or ICI related
- Pneumonitis ii. Bronchopulmonary hemorrhage iii. Abdominal hemorrhage e. Unresolved GI related events i. Diverticulitis ii. Colitis iii. Intra-abdominal abscess iv. GI obstructions v. Abdominal carcinomatosis vi. Any known risk factor for bowel perforation
- History of severe (Grade ≥ 3) immune-related adverse events observed with previous immunotherapy (anti-PD-1/L1) or known sensitivity (Grade ≥ 3) to any excipients.
- Has received any approved or investigational anti-neoplastic agent or immunotherapy within 2 weeks prior to NBTXR3 injection.
- Except anti-PD-1/L1, which will not require a washout window.
- A reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
- Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement [≤ 10 mg prednisone] therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Any live-virus vaccine used for prevention of infectious diseases administered within 4 weeks prior to NBTXR3 injection.
- Except killed-virus Influenza vaccine
- Exception of other vaccines (e.g. pneumonia) is at the discretion of the treating physician after conducting a personalized risk assessment on a case by case basis.
- Prior allogenic stem cell transplantation or organ allograft.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment.
- Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection.
- Female patients who are pregnant or breastfeeding.
- Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 160 days (~5.33 months) for female participants, and 7 months for males participants or female partners of male participants that are of child-bearing potential, after the last dose of anti-PD-1/L-1.
- Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of < 1% per year when used consistently and correctly.
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Saumil Gandhi, MD, 713-606-2413, sngandhi@mdanderson.org
Saumil Gandhi, MD
About this study
This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with Anti PD-1 / PD-L1 monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, Anti PD-1 / PD-L1 may help to control the disease.
Read the detailed description
Primary Objective
Phase I \& II
- To evaluate efficacy and safety of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1)
Secondary Objective:
- To evaluate the safety profile of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1).
- To evaluate time-to-event outcomes of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1).
Exploratory Objectives:
- To evaluate radiomic measurements with outcomes of study treatments.
II. To evaluate biomarkers of response in subjects after receiving study treatment.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for up to 2 years post-radiation therapy.
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Metastatic Malignant Solid Neoplasm
- Being tested
- Hafnium Oxide-containing Nanoparticles NBTXR3, Radiation Therapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hafnium Oxide-containing Nanoparticles NBTXR3Other
Also called NBTXR3
Given intratumorally
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Undergo Abscopal radiation therapy
Radiation TherapyRadiation
Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated
Undergo RadScopal radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1 | Experimental | COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity. Receives: Other: Hafnium Oxide-containing Nanoparticles NBTXR3; Radiation: Radiation Therapy |
| Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1 | Experimental | COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity. Receives: Other: Hafnium Oxide-containing Nanoparticles NBTXR3; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities
Descriptive summary tables will be produced.
Measured: Up to 4 weeks post radiation therapy
Objective response rate
Defined as percentage of patients achieving complete or partial response, per immune-related Response Evaluation Criteria In Solid Tumors (irRECIST). The best overall response will be provided per irRECIST criteria and consideration of all imaging assessment is required.
Measured: Up to 12 weeks post radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start8 May 2023
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Saumil Gandhi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039632
- Sponsor's protocol ID
- 2020-0618
- Other IDs
- NCI-2021-09077, 2020-0618
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT05039632
- Acronym / sponsor ID
- 2020-0618
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Metastatic Malignant Solid Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 9 Sep 2021 (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 phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with Anti PD-1 / PD-L1 monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, Anti PD-1 / PD-L1 may help to control the disease.
Detailed description
Primary Objective
Phase I \& II
- To evaluate efficacy and safety of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1)
Secondary Objective:
- To evaluate the safety profile of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1).
- To evaluate time-to-event outcomes of NBTXR3 activated by radiation (Abscopal or RadScopal™) in combination with immunotherapy ( anti-PD-1/L-1).
Exploratory Objectives:
- To evaluate radiomic measurements with outcomes of study treatments.
II. To evaluate biomarkers of response in subjects after receiving study treatment.
OUTLINE: Patients are randomized to 1 of 2 cohorts.
COHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for up to 2 years post-radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1 | Experimental | Other: Hafnium Oxide-containing Nanoparticles NBTXR3, Radiation: Radiation TherapyCOHORT I: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) intravenously (IV) on day 8. Beginning day 15, patients undergo Abscopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1) repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity. |
| Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1 | Experimental | Other: Hafnium Oxide-containing Nanoparticles NBTXR3, Radiation: Radiation TherapyCOHORT II: Patients receive NBTXR3 intratumorally on day 1. Patients also receive ( anti-PD-1/L-1) IV on day 8. Beginning day 15, patients undergo RadScopal radiation therapy over 1-2 weeks. Cycles with ( anti-PD-1/L-1)repeat every 3-6 weeks per standard of care up to 2 years in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (53 listed)
- Patients with metastatic disease in the lung and/or liver, or soft tissue from any primary malignancy considered incurable by local therapies.
- The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable.
- Amenable to undergo the image guided (EBUS or CT or MRI) intratumoral injection of NBTXR3, in up to two (2) high dose target lesions, as determined by the investigator or treating physician at screening.
- Selected high and low dose target lesions must be amenable to receive radiation therapy as determined by the investigator or treating radiation oncologist.
- Patients can receive radiation therapy for symptomatic metastatic disease prior to enrollment or during the study a.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hafnium Oxide-containing Nanoparticles NBTXR3Also: NBTXR3Given intratumorally | Other | Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1, Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1 |
| Radiation TherapyAlso: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, IrradiatedUndergo Abscopal radiation therapy | Radiation | Cohort I (NBTXR3, Abscopal, Anti PD-1 / PD-L1 |
| Radiation TherapyAlso: Cancer Radiotherapy, ENERGY_TYPE, Irradiate, IrradiatedUndergo RadScopal radiation therapy | Radiation | Cohort II (NBTXR3, RadScopal, Anti PD-1 / PD-L1 |
Primary outcome
Incidence of dose limiting toxicities
Time frame: Up to 4 weeks post radiation therapy
Descriptive summary tables will be produced.
Objective response rate
Time frame: Up to 12 weeks post radiation therapy
Defined as percentage of patients achieving complete or partial response, per immune-related Response Evaluation Criteria In Solid Tumors (irRECIST). The best overall response will be provided per irRECIST criteria and consideration of all imaging assessment is required.
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 30 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Saumil Gandhi, MD principal investigator
M.D. Anderson Cancer Center
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 Hafnium Oxide-containing Nanoparticles NBTXR3 and Radiation Therapy in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Liver, run by M.D. Anderson Cancer Center 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 53 inclusion and 0 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 30 Jul 2026. 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 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 Nathan Comeaux (832-728-0689, nicomeaux@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (time frame: Up to 4 weeks post radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.