NeuroblastomaPhase 1/2NCT04023331
67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma
A Phase 1/2 study testing 67Cu-SARTATE and 64Cu-SARTATE in people with Neuroblastoma and Relapsed Neuroblastoma, run by Clarity Pharmaceuticals Ltd at 8 sites in United States.
Trial summary
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuroblastoma, Relapsed Neuroblastoma, Refractory Neuroblastoma
- What is being tested?
- 67Cu-SARTATE and 64Cu-SARTATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesUnited States
- Study dates
- 18 Aug 2020to 25 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant is able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor participants, with the minor providing age appropriate assent, according to local law and regulations;
- Life expectancy ≥ 12 weeks for patients in the Dose Escalation Phase or ≥ 4 months for patients in the Cohort Expansion Phase;
- Known high-risk neuroblastoma OR previously intermediate-risk neuroblastoma that has relapsed or progressed to high-risk, with failure to achieve complete response with standard therapy (defined as at least 4 cycles of aggressive multi-drug induction chemotherapy with or without radiation and surgery, or according to a standard high-risk treatment/neuroblastoma protocol), OR who are medically ineligible to receive standard treatment OR who are intolerant to standard treatment;
- Adequate recovery from acute toxic effects of any prior therapy, as deemed by the Investigator or treating Sub-Investigator;
- Adequate liver function as defined by the following laboratory values obtained within 28 days prior to administration of 64Cu-SARTATE: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN);
- Adequate renal function;
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- Adequate laboratory parameters: Absolute neutrophil count > 1.0 x 10 9/L; Platelet count > 50 x 10 9/L; Total bilirubin <1.5 x ULN;
- Karnofsky or Lansky performance status ≥50;
- All participants must have a hematopoietic stem cell product available (minimum CD34+ cell dose is ≥2 x 10 6 cells/kg);
- Sexually active participants of reproductive potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus. Abstinence is considered acceptable;
- 64Cu-SARTATE uptake on the 4 hour scan (SUVmax) of any lesion equal to or higher than that of the liver in order to move on to the therapy phase of the study.
Who cannot join
- Participants with disease of any major organ system that would compromise their ability to tolerate therapy, as deemed by the Investigator or treating Sub-Investigator;
- Participants with intracranial tumor affecting the brain parenchyma that has not been previously treated at the time of study enrolment;
- Any other active malignancy, or a history of prior malignancy within the past 3 years;
- History of cardiac failure as evidenced by: dyspnea at rest, exercise intolerance, oxygen requirement, clinically significant cardiac dysfunction;
- Planned administration of chemotherapy, anti-cancer cytokine therapy, immunotherapy or radiotherapy within 2 weeks prior to the administration of 64Cu-SARTATE;
- Administration of therapeutic dose of 131I-MIBG within 8 weeks prior to the administration of 64Cu-SARTATE;
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- External beam radiation therapy (EBRT) to both kidneys or a single functioning kidney within 12 months prior to the administration of 64Cu-SARTATE;
- Administration of any investigational agents within 21 days prior to administration of 64Cu-SARTATE;
- Treatment with long acting somatostatin analogues (administered within 28 days prior to the administration of 64Cu-SARTATE), or short acting somatostatin analogues (administered within 24 hours prior to the administration of 64Cu-SARTATE);
- Known sensitivity or allergy to somatostatin analogues;
- Previous peptide receptor radionuclide therapy (PRRT);
- Female participants who are pregnant or lactating;
- Participants who are on hemodialysis;
- QTcF interval ≥ 0.45 seconds as measured by Screening ECG;
- Participants with uncontrolled infection(s);
- Any medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
- Participants 12 months and younger will be excluded from cohorts where the planned single or cumulative administered activity is modelled to deliver a radiation dose to the marrow that exceeds 2 Gy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Centre
Cincinnati, Ohio, 45229
University of Texas Southwestern Medical Centre
Dallas, Texas, 75390
MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin
Madison, Wisconsin, 53792
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
Read the detailed description
This is an 'adaptive trial'. The trial design uses the accumulating data from the ongoing trial to modify aspects of the trial (e.g. dose, number of treatments). The trial is also a 'personalised trial' as the interval between treatments and number of treatments is determined for each patient individually.
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase.
Dose escalation will be completed using a modified 3+3 study design with up to 7 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 1 therapy cycle of 67Cu-SARTATE.
Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the International Neuroblastoma Response Criteria (INRC) guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Cohort expansion will commence once either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose (MFD) for a single administration of 67Cu-SARTATE is established, or Cohort 7 has been completed. The study will be expanded to enroll an additional 10 subjects who will receive at least 2 therapy cycles of 67Cu-SARTATE at the MTD/MFD dose level. Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the INRC guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
The study also includes a long-term follow-up period to 36 months following the first dose of 67Cu-SARTATE, although in person study visits are not required.
- Being tested
- 67Cu-SARTATE, 64Cu-SARTATE
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
67Cu-SARTATEDrug
Also called Cu-67 SARTATE, copper 67 SARTATE
67Cu-labelled MeCOSar-Tyr3-octreotate
64Cu-SARTATEDrug
Also called Cu-64 SARTATE, copper 64 SARTATE
64Cu-labelled MeCOSar-Tyr3-octreotate
| Study group | Role | What they receive |
|---|---|---|
| 67Cu-SARTATE | Experimental | 64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle, at a rate of 2.0 MBq/kg.
67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as an IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive at least 2 administrations of 67Cu-SARTATE at the MTD/MFD level as a slow IV infusion.
Participants in either phase of the study that demonstrate therapeutic benefit following treatment with 67Cu-SARTATE at any dose may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total). Receives: Drug: 67Cu-SARTATE; Drug: 64Cu-SARTATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)/Maximum Feasible Dose (MFD) of 67Cu-SARTATE
MDT/MFD as determined by cohort observations of Dose Limiting Toxicities
Measured: 6 weeks
Safety and tolerability of 67Cu-SARTATE using Common Terminology Criteria for Adverse Events (CTCAE)
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, electrocardiograms (ECGs) and spontaneous adverse event (AE) reporting.
Measured: Up to 36 months
Safety and tolerability of 64Cu-SARTATE using CTCAE
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
Measured: Up to 36 months
Overall response rate
As assessed by international neuroblastoma response criteria (INRC).
Measured: Up to 12 months
Best response
As assessed by international neuroblastoma response criteria (INRC).
Measured: 6 to 8 weeks post final therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start18 Aug 2020
- Primary completion24 Jan 2025
- Study completion25 Mar 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023331
- Sponsor's protocol ID
- CL04
- Status last verified
- Sep 2025
- First submitted
- 14 Jul 2019
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial
- ClinicalTrials.gov ID
- NCT04023331
- Acronym / sponsor ID
- CL04
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 17 Jul 2019 (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.
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
Detailed description
This is an 'adaptive trial'. The trial design uses the accumulating data from the ongoing trial to modify aspects of the trial (e.g. dose, number of treatments). The trial is also a 'personalised trial' as the interval between treatments and number of treatments is determined for each patient individually.
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase.
Dose escalation will be completed using a modified 3+3 study design with up to 7 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 1 therapy cycle of 67Cu-SARTATE.
Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the International Neuroblastoma Response Criteria (INRC) guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
Cohort expansion will commence once either the Maximum Tolerated Dose (MTD) or the Maximum Feasible Dose (MFD) for a single administration of 67Cu-SARTATE is established, or Cohort 7 has been completed. The study will be expanded to enroll an additional 10 subjects who will receive at least 2 therapy cycles of 67Cu-SARTATE at the MTD/MFD dose level. Participants who demonstrate therapeutic benefit (defined as non progression as assessed by the Investigator using the INRC guidelines) may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total).
The study also includes a long-term follow-up period to 36 months following the first dose of 67Cu-SARTATE, although in person study visits are not required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 67Cu-SARTATE | Experimental | Drug: 67Cu-SARTATE, Drug: 64Cu-SARTATE64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle, at a rate of 2.0 MBq/kg. 67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as an IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive at least 2 administrations of 67Cu-SARTATE at the MTD/MFD level as a slow IV infusion. Participants in either phase of the study that demonstrate therapeutic benefit following treatment with 67Cu-SARTATE at any dose may be offered additional Therapy Cycles (each participant may receive a maximum of 4 Therapy Cycles in total). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Participant is able and willing to provide informed consent (≥18 years), or informed consent is obtained by the parent or legal guardian for minor participants, with the minor providing age appropriate assent, according to local law and regulations;
- Life expectancy ≥ 12 weeks for patients in the Dose Escalation Phase or ≥ 4 months for patients in the Cohort Expansion Phase;
- Known high-risk neuroblastoma OR previously intermediate-risk neuroblastoma that has relapsed or progressed to high-risk, with failure to achieve complete response with standard therapy (defined as at least 4 cycles of aggressive multi-drug induction chemotherapy with or without radiation and surgery, or according to a standard high-risk treatment/neuroblastoma protocol), OR who are medically ineligible to receive standard treatment OR who are intolerant to standard treatment;
- Adequate recovery from acute toxic effects of any prior therapy, as deemed by the Investigator or treating Sub-Investigator;
- Adequate liver function as defined by the following laboratory values obtained within 28 days prior to administration of 64Cu-SARTATE: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x upper limit of normal (ULN);
Key exclusion criteria (17 listed)
- Participants with disease of any major organ system that would compromise their ability to tolerate therapy, as deemed by the Investigator or treating Sub-Investigator;
- Participants with intracranial tumor affecting the brain parenchyma that has not been previously treated at the time of study enrolment;
- Any other active malignancy, or a history of prior malignancy within the past 3 years;
- History of cardiac failure as evidenced by: dyspnea at rest, exercise intolerance, oxygen requirement, clinically significant cardiac dysfunction;
- Planned administration of chemotherapy, anti-cancer cytokine therapy, immunotherapy or radiotherapy within 2 weeks prior to the administration of 64Cu-SARTATE;
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 |
|---|---|---|
| 67Cu-SARTATEAlso: Cu-67 SARTATE, copper 67 SARTATE67Cu-labelled MeCOSar-Tyr3-octreotate | Drug | 67Cu-SARTATE |
| 64Cu-SARTATEAlso: Cu-64 SARTATE, copper 64 SARTATE64Cu-labelled MeCOSar-Tyr3-octreotate | Drug | 67Cu-SARTATE |
Primary outcome
Maximum Tolerated Dose (MTD)/Maximum Feasible Dose (MFD) of 67Cu-SARTATE
Time frame: 6 weeks
MDT/MFD as determined by cohort observations of Dose Limiting Toxicities
Safety and tolerability of 67Cu-SARTATE using Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Up to 36 months
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, electrocardiograms (ECGs) and spontaneous adverse event (AE) reporting.
Safety and tolerability of 64Cu-SARTATE using CTCAE
Time frame: Up to 36 months
Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
Overall response rate
Time frame: Up to 12 months
As assessed by international neuroblastoma response criteria (INRC).
Best response
Time frame: 6 to 8 weeks post final therapy
As assessed by international neuroblastoma response criteria (INRC).
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 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 67Cu-SARTATE and 64Cu-SARTATE in people with Neuroblastoma and Relapsed Neuroblastoma, run by Clarity Pharmaceuticals Ltd at 8 sites 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 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD)/Maximum Feasible Dose (MFD) of 67Cu-SARTATE (time frame: 6 weeks). The study lists 5 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 16 Sep 2025.