34 Participants Needed

Peptide Receptor Radionuclide Therapy for Neuroblastoma

Recruiting at 8 trial locations
CP
Overseen ByClarity Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment called 67Cu-SARTATE for children with high-risk neuroblastoma. The treatment uses radiation to target and kill cancer cells. The goal is to see if this approach is safe and effective for these patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot have chemotherapy, anti-cancer cytokine therapy, immunotherapy, or radiotherapy within 2 weeks before the trial, and certain other treatments have specific time restrictions.

Is Peptide Receptor Radionuclide Therapy using Cu-SARTATE safe for humans?

The safety data for Cu-SARTATE is primarily from preclinical studies in mice, which showed its potential for detecting and treating neuroblastoma. While these studies are promising, they do not provide direct evidence of safety in humans.12345

How is the drug 67Cu-SARTATE different from other treatments for neuroblastoma?

67Cu-SARTATE is unique because it targets a specific receptor (SSTR2) found on most neuroblastoma tumors, allowing it to both detect and treat the disease. This dual function, known as a theranostic approach, uses a diagnostic agent to identify the cancer and a therapeutic agent to treat it, which is not common in standard neuroblastoma treatments.12346

What data supports the effectiveness of the treatment 64Cu-SARTATE and 67Cu-SARTATE for neuroblastoma?

Research shows that 64Cu-SARTATE can detect neuroblastoma cells, and 67Cu-SARTATE can treat them by targeting a specific receptor (SSTR2) found on most neuroblastoma tumors. In preclinical studies with mice, this approach helped identify and reduce minimal residual disease (small amounts of cancer that remain after treatment).12345

Are You a Good Fit for This Trial?

This trial is for pediatric patients with high-risk neuroblastoma that's relapsed or not responding to standard treatments. They must have a life expectancy of at least 12 weeks, adequate organ function, and a minimum performance status of 50. Participants need available stem cells for transplant and must use effective birth control if applicable.

Inclusion Criteria

I can do most activities but may need help.
My neuroblastoma is high-risk and hasn't fully responded to standard treatments.
My scan shows a lesion as active as or more than my liver.
See 7 more

Exclusion Criteria

I received a specific radioactive treatment within the last 8 weeks.
My major organs are healthy enough to handle the treatment.
I have undergone peptide receptor radionuclide therapy.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Dose Escalation

Participants receive a single administration of 67Cu-SARTATE as an IV infusion with dose escalation based on cohort allocation. Dose Limiting Toxicities are monitored for 6 weeks post administration.

6 weeks

Cohort Expansion

Participants receive at least 2 therapy cycles of 67Cu-SARTATE at the Maximum Tolerated Dose (MTD) level. Additional therapy cycles may be offered based on therapeutic benefit.

Variable, up to 4 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments up to 36 months following the first dose.

36 months
No in-person visits required

What Are the Treatments Tested in This Trial?

Interventions

  • 64Cu-SARTATE
  • 67Cu-SARTATE
Trial Overview The study tests the safety and effectiveness of a therapy called 67Cu-SARTATE in children with aggressive neuroblastoma. Patients first undergo a scan using 64Cu-SARTATE to ensure their tumors absorb the drug well enough before receiving the actual treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 67Cu-SARTATEExperimental Treatment2 Interventions

67Cu-SARTATE is already approved in United States for the following indications:

🇺🇸
Approved in United States as 67Cu-SARTATE for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Clarity Pharmaceuticals Ltd

Lead Sponsor

Trials
11
Recruited
720+

Published Research Related to This Trial

The study demonstrated that [64Cu]Cu-SARTATE effectively targets and detects neuroblastoma tumors expressing the SSTR2 receptor, with significant uptake in viable tumor regions and rapid clearance from non-target tissues, particularly the kidneys.
Therapeutic use of [67Cu]Cu-SARTATE starting two weeks after tumor cell inoculation significantly extended survival in a preclinical model of neuroblastoma by an average of 13 days, highlighting its potential as a treatment for minimal residual disease.
Detection and therapy of neuroblastoma minimal residual disease using [64/67Cu]Cu-SARTATE in a preclinical model of hepatic metastases.Dearling, JLJ., van Dam, EM., Harris, MJ., et al.[2021]
The peptide-linked copper chelator DOTA-R1-F(ab')2 showed superior performance in targeting neuroblastoma tumors, with higher tumor uptake and better tumor-to-tissue ratios compared to other conjugates in a mouse model.
CPTA-R1-F(ab')2 demonstrated improved biodistribution by reducing radioactivity in the kidneys, which may enhance safety and efficacy in therapeutic applications.
A triglycine linker improves tumor uptake and biodistributions of 67-Cu-labeled anti-neuroblastoma MAb chCE7 F(ab')2 fragments.Zimmermann, K., Gianollini, S., Schubiger, PA., et al.[2019]
The study highlights the potential of using [64/67Cu]Cu-SARTATE as a theranostic tool for detecting and treating SSTR2-positive neuroblastoma in pediatric patients, particularly for addressing minimal residual disease after initial therapy.
The authors propose a new therapy-dosimetric equation to improve the estimation of therapeutic dosages based on initial diagnostic scans, which could enhance the effectiveness of future clinical applications of this approach.
An abbreviated therapy-dosimetric equation for the companion diagnostic/therapeutic [64/67Cu]Cu-SARTATE.Laffon, E., de Clermont, H., Marthan, R.[2021]

Citations

Detection and therapy of neuroblastoma minimal residual disease using [64/67Cu]Cu-SARTATE in a preclinical model of hepatic metastases. [2021]
A triglycine linker improves tumor uptake and biodistributions of 67-Cu-labeled anti-neuroblastoma MAb chCE7 F(ab')2 fragments. [2019]
An abbreviated therapy-dosimetric equation for the companion diagnostic/therapeutic [64/67Cu]Cu-SARTATE. [2021]
Recent Advances in 64Cu/67Cu-Based Radiopharmaceuticals. [2023]
Tumor uptake and metabolism of copper-67-labeled monoclonal antibody chCE7 in nude mice bearing neuroblastoma xenografts. [2015]
Translational immunoPET imaging using a radiolabeled GD2-specific antibody in neuroblastoma. [2022]
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