hu14 + Chemotherapy for Neuroblastoma

(SHINE Trial)

Recruiting at 1 trial location

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Renaissance Pharma Ltd.

Must not be taking: Systemic corticosteroids, Immunosuppressives, Anticonvulsants

Disqualifiers: Infections, Organ transplant, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for high-risk neuroblastoma, a cancer that mostly affects young children. Researchers aim to evaluate the safety and effectiveness of using a monoclonal antibody called hu14.18K322A with chemotherapy. The trial includes two groups testing different doses to determine the best approach. Children and teens with neuroblastoma that has spread and who have completed major treatments like surgery may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications before joining the trial. There are specific time periods you must wait after stopping some treatments, like chemotherapy or steroids, before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatment hu14.18K322A, when combined with chemotherapy, is generally safe for patients with high-risk neuroblastoma. In a study with 64 patients, this combination was mostly well-tolerated, though some patients required continuous pain relief. Another study found that the treatment was not only tolerable but also effective in patients whose neuroblastoma had returned. While some discomfort may occur, serious side effects are rare. Overall, these findings reassure those considering joining the trial about the treatment's safety. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for neuroblastoma?

Researchers are excited about hu14.18K322A for neuroblastoma because it offers a unique approach compared to standard treatments like chemotherapy alone. Most neuroblastoma treatments work by attacking rapidly dividing cells, but hu14.18K322A is an antibody that specifically targets the GD2 antigen present on neuroblastoma cells, potentially increasing precision and reducing harm to healthy cells. Additionally, this treatment is being tested in both higher and lower doses, which could offer more personalized treatment options for patients based on their specific needs.

What evidence suggests that hu14.18K322A with chemotherapy might be an effective treatment for neuroblastoma?

Research has shown that the monoclonal antibody hu14.18K322A, when combined with chemotherapy, holds promise for treating high-risk neuroblastoma in children. Studies found that adding this antibody to chemotherapy improves early treatment responses, achieving a 66.7% success rate compared to 39.1% with chemotherapy alone. Additionally, most patients experienced a significant reduction in tumor size. One study noted a 20% increase in survival rates for children with high-risk neuroblastoma. In this trial, participants will receive either a higher or lower dose of hu14.18K322A alongside chemotherapy. These findings suggest that hu14.18K322A may enhance the immune system's ability to target and fight cancer cells, increasing treatment effectiveness. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children and teens aged 18 months to under 18 years with high-risk neuroblastoma that has spread. Participants must have good heart, liver, kidney, and bone marrow function, be at least two weeks past major surgery, and have recovered from previous treatments.

Inclusion Criteria

I had major tumor surgery more than 2 weeks ago.

1. BM function: i. Platelets ≥50 × 109/L ii. Absolute neutrophil count (ANC) ≥0.50 × 109/L

3. Have evaluable or measurable disease per International Neuroblastoma Response Criteria (INRC)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

The first part of the study will test two doses of hu14.18K322A to give with chemotherapy in 12 patients to confirm the best dose

Up to 12 months

Treatment

Participants receive up to 12 cycles of hu14.18K322A in combination with chemotherapy

Up to 12 months

Follow-up

Participants are monitored for long-term effects after treatment

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• hu14.18K322A

Trial Overview

The study tests a new antibody treatment called hu14.18K322A (daretabart) combined with chemotherapy drugs temozolomide and irinotecan in young people with high-risk neuroblastoma to see how safe and effective this combination is.

How Is the Trial Designed?

Group I: Lower dose Experimental Treatment 1 Intervention

Group II: Higher dose Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Renaissance Pharma Ltd.

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8797508/

Updated Results of a Phase II Study Using hu14.18K322A

18K322A to induction chemotherapy significantly improves early responses in patients with newly diagnosed HR neuroblastoma (66.7% v 39.1%; 95% CI 55.0 to 78.3 v ...

2.

ascopubs.org

ascopubs.org/doi/abs/10.1200/JCO.21.01375

Updated Results of a Phase II Study Using hu14.18K322A

Adding hu14.18K322A to induction chemotherapy improved early objective responses, significantly reduced tumor volumes in most patients, improved ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34871104/

Updated Results of a Phase II Study Using hu14.18K322A

Adding hu14.18K322A to induction chemotherapy improved early objective responses, significantly reduced tumor volumes in most patients, improved end-of- ...

4.

stjude.org

stjude.org/media-resources/news-releases/2021-medicine-science-news/chemoimmunotherapy-dramatically-improved-survival-of-high-risk-neuroblastoma-patients.html

Chemoimmunotherapy dramatically improved survival of ...

Survival rates increased about 20% for children with high-risk neuroblastoma enrolled in a St. Jude Children's Research Hospital clinical trial.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07549321

A Safety and Efficacy Study of hu14 in High-Risk ...

This is a Phase 2/3, open label, single arm study, evaluating how well hu14.18K322A works and how safe it is in combination with chemotherapy, ...

6.

mdpi.com

mdpi.com/2072-6694/16/11/2064

Hu14.18K.322A Causes Direct Cell Cytotoxicity and ...

The main aim of this study was to understand if hu14.18K322A, an antibody targeting GD2, causes direct cell death in high-risk neuroblastoma and to delineate ...

7.

aacrjournals.org

aacrjournals.org/clincancerres/article/23/21/6441/260123/A-Pilot-Trial-of-Humanized-Anti-GD2-Monoclonal

A Pilot Trial of Humanized Anti-GD2 Monoclonal Antibody ...

18K322A can be safely combined with three standard neuroblastoma chemotherapeutic regimens, cytokines, and NK cells in the treatment of recurrent or refractory ...