SODIUM 2-HYDROXYLINOLEATE for Relapsed/refractory neuroblastoma | Other relapsed/refractory solid tumours

Inclusion criteria

• {"criterion_text":"- 1. Signed informed consent of the patient, parents or legal representatives before any study-specific screening procedures are conducted, and age-appropriate assent.\n- 2. Aged 1 to ≤21 years at time of signing informed consent.\n- 3. BSA ≥0.5 m2 .\n- 4. Patient must be able to swallow intact capsules.\n- 5. Diagnosis of a solid tumour that has progressed, relapsed or is refractory to at least one standard therapy and/or for which there is not known curative option. Histologic confirmation of progression or relapse is recommended but not mandatory.\n- 6. At least one evaluable or measurable radiological site of disease as defined by INRC, RECIST v1.1 or RAPNO criteria.\n- 7. Adequate performance status: Patients 60%. Patients ≥16 years of age: Karnofsky >60%.\n- 8. Adequate haematological, hepatic and renal function defined by the following laboratory results obtained within 7 days prior to initiation of study drug according to CTCAE v5.0:\n*Haematological function: - Haemoglobin ≥ 8 g/dL (transfusion allowed). - Peripheral ANC ≥1x109 /L. No G-CSF support for 72 hours prior to initiation of study treatment. Pegylated forms need a wash-out of 7 days. - Platelet count ≥75x109 /L, unsupported for 72 hours prior to initiation of study treatment. *Renal and liver function: - Normal serum creatinine based on age/gender. If serum creatinine is greater than maximum serum creatinine for age/gender, then creatinine clearance (or radioisotope glomerular filtration rate [GFR]) must be >70 mL/min/1.73m2 . - Total bilirubin ≤1.5 x ULN (≤3 x ULN if liver metastases). - AST or ALT ≤3 x ULN (≤5 x ULN if liver metastases).\n- 9. Appropriate contraceptive methods for sexually active males and women of childbearing age.\n- 10. A negative pregnancy test for women of childbearing age.\n- 11. Absence of any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up Schedule"}

Exclusion criteria

• {"criterion_text":"- 1. Symptomatic or bleeding CNS metastases that result in a neurologically unstable clinical state or require increasing doses of corticosteroids or local CNS-directed therapy to control.\n- 2. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of ABTL0812 or temozolomide.\n- 3. Any additional uncontrolled illness or known active infection, including HBV, HCV and HIV.\n- 4. Presence of any grade >2 clinically significant toxicities related to prior treatments with the exception of alopecia, peripheral neuropathy or other long-term sequelae of cancer therapy, and parameters otherwise permitted in the inclusion criteria.\n- 5. Any uncontrolled medical condition or other identified abnormality that precludes the patient's safe participation in and completion of the study, as judged by the investigator.\n- 6. Systemic anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Seven days for oral metronomic chemotherapy.\n- 7. I-131 MIBG therapy within 6 weeks prior to initiation of study treatment.\n- 8. Myeloablative therapy with autologous hematopoietic stem cell rescue within 60 days or allogeneic hematopoietic stem cell rescue within 120 days of study treatment initiation.\n- 9. Active graft versus host disease requiring systemic therapy.\n- 10. Radiotherapy (non-palliative) within 21 days prior to study treatment initiation.\n- 11. Major surgical procedure within 21 days of study treatment initiation, or anticipated need for major surgical procedure during the course of the study"}

Primary endpoints

• {"endpoint_text":"- Incidence of dose limiting toxicities assessed during the first cycle of study treatment of ABTL0182 (cohorts A and B).","definition_or_measurement_approach":"Incidence of dose-limiting toxicities (DLTs) assessed during the first cycle of study treatment (cycle length defined per cohort: cohort A first cycle 28 days; cohort B first cycle effectively 28 days due to 7-day single-agent loading followed by combination). DLTs evaluated according to CTCAE v5.0 as implicit from eligibility/laboratory criteria."}

Spain

Earliest CTIS Part Ii Submission Date

24-10-2024

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

522

Number Of Sites

7

Number Of Participants

48

Primary sponsor

Full Name

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain