Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hu5F9-G4 · 2 trials · 3 indications
MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT).
The CTCAE criteria will be used to assess adverse events on this trial.
| Arm | Type | Description |
|---|---|---|
| Hu5F9-G4 | EXPERIMENTAL | Dose Escalation: CD47 blocking antibody Hu5F9-G4 |
| Treatment (Hu5F9-G4) | EXPERIMENTAL | Hu5F9-G4 monotherapy |
| Name | Type | Description |
|---|---|---|
| Hu5F9-G4 | DRUG | - |
Key Inclusion Criteria: * Pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) Acute Myeloid Leukemia (AML) (defined by World Health Organization (WHO) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplast...
Hu5F9-G4 is an investigational anti-CD47 antibody being studied for use in Acute Myeloid Leukemia, Solid Tumor, and Myelodysplastic Syndrome. It is in Phase 1 clinical development for these oncology indications.
Hu5F9-G4 targets CD47, a protein often overexpressed on cancer cells to evade immune destruction. By blocking CD47, the antibody aims to enhance the immune system's ability to eliminate tumor cells.
Hu5F9-G4 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD.
Hu5F9-G4 is in Phase 1 clinical development. It is investigational and not yet approved by regulatory authorities. Two Phase 1 trials have been completed.
Hu5F9-G4 has been studied in two completed Phase 1 trials: NCT02216409, a trial in patients with solid tumors in the United States, and NCT02678338, the CAMELLIA trial in haematological malignancies including Acute Myeloid Leukemia and Myelodysplastic Syndrome in the United Kingdom.
Hu5F9-G4 is also known as magrolimab. It is an anti-CD47 antibody being developed by Gilead Sciences for oncology indications.