Testing GAIA-102 for difficult-to-treat pediatric cancers
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
This study is testing a new treatment called GAIA-102 for children with tough-to-treat cancers to see if it’s safe and how much of it they should get.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 1 Year to 24 Years |
| Sex | All |
| Sponsor | Kyushu University Academic / other |
| Drugs / interventions | dinutuximab, Nivolumab |
| Locations | 1 site (Fukuoka, Fukuoka) |
| Trial ID | NCT05608148 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and recommended dosing of GAIA-102 in children with refractory or relapsed neuroblastoma and other malignant solid tumors. It consists of three cohorts: one testing GAIA-102 alone, another combining it with Dinutuximab, and a third with Nivolumab. The study aims to determine the safety of these combinations and establish appropriate doses for future phases. The trial focuses on patients who have not responded to standard treatments and have specific types of tumors.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 24 with refractory or relapsed neuroblastoma or other specified malignant solid tumors.
Not a fit: Patients with brain tumors or those who have not undergone multiple treatment regimens may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for children with hard-to-treat cancers.
How similar studies have performed: Other studies have shown promise with similar biological treatments, but this specific combination approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have been confirmed to have the following malignant tumor by histological examination * cohort A : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) . * cohort B : neuroblastoma. * cohort C \& D : neuroblastoma and other malignant solid tumors, rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma. 2. Undergoing the following treatment. * cohort A \& B : Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline. * cohort C \& D : Patients with neuroblastoma who have completed the dinutuximab regimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline. 3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs. 4. Patients aged from 1years to 24 years at the time of obtaining consent. 5. Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent. Exclusion Criteria: 1. Patients with brain metastases. 2. Patients diagnosed with cancerous meningitis 3. Patients who received allogeneic hematopoietic stem cell transplant. 4. Patients with active autoimmune disease.
Where this trial is running
Fukuoka, Fukuoka
- Kyushu University Hospital — Fukuoka, Fukuoka, Japan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.