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Also known as Hu3F8 With GM-CSF
Hu3F8 · 1 trial · 1 indication
The regimen will be considered safe if there are no toxicities requiring discontinuation of therapy in at least 9/10 patients during the first two cycles.
Response assessment will be based on the best response over the course of four cycles. Disease response for NB will use the International NB Response Criteria. Patients who withdraw from the study prior to cycle 4 with \< partial response will also not be considered evaluable for response and will be replaced.
| Arm | Type | Description |
|---|---|---|
| Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) | EXPERIMENTAL | Each cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. |
| Name | Type | Description |
|---|---|---|
| Irinotecan | DRUG | 50mg/m\^2/day IV will be administered from day 1-5 |
| temozolomide | DRUG | (given concurrently with Irinotecan) 150mg/m\^2/day orally |
| Hu3F8 | BIOLOGICAL | 2.25mg/kg IV will be administered on days 2, 4, 8 and 10 |
| GM-CSF | DRUG | 250mcg/m2/day SC will be administered on days 6-10 |
Inclusion Criteria: * Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels * High-risk NB as defined as any of the following: * Stage 4 with MYCN amplification (any a...
Hu3F8 is an investigational monoclonal antibody being studied for the treatment of neuroblastoma, a type of cancer that forms in nerve tissue. It is being evaluated in patients with relapsed or refractory high-risk neuroblastoma and in those in first remission of high-risk neuroblastoma.
Hu3F8 is being developed by Y-mAbs Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of Hu3F8 in patients with neuroblastoma.
Hu3F8 is in clinical development, with trials listed as Phase 1, Phase 2, and Early Phase 1. It is an investigational drug and has not been approved by the FDA. The trials are studying its use in different stages of high-risk neuroblastoma.
Hu3F8 is being studied in three clinical trials. NCT01757626 is a Phase 1 trial combining Hu3F8 with GM-CSF in relapsed or refractory high-risk neuroblastoma. NCT03033303 is a Phase 2 trial of Hu3F8/GM-CSF plus isotretinoin in first remission. NCT03189706 is an Early Phase 1 trial of chemoimmunotherapy for high-risk neuroblastoma.
Hu3F8 is sometimes referred to as Hu3F8 With GM-CSF, which describes the combination therapy being tested. The drug itself is the monoclonal antibody Hu3F8, and GM-CSF is a separate agent used alongside it in certain clinical trials.