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Also known as a human monoclonal anti-KIR antibody (1-7F9), Fully human anti-KIR monoclonal antibody (1-7F9)
IPH2101 · 3 trials · 3 indications
The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.
Response was defined: * In patients with a serum M-protein \> 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval; * In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis * In patients with serum M-protein \< 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (\<0.26 or \> 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.
using the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
| Arm | Type | Description |
|---|---|---|
| IPH2101 0.2 mg/kg | EXPERIMENTAL | 0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
| IPH2101 2 mg/kg | EXPERIMENTAL | 2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
| IPH 2101 0.2 mg/kg | EXPERIMENTAL | One infusion of IPH2101 every 4 weeks at the dose of 0.2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. |
| IPH2101 2.0 mg/kg | EXPERIMENTAL | One infusion of IPH2101 every 4 weeks at the dose of 2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. |
| IPH2101 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IPH2101 | DRUG | 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles |
Inclusion Criteria: 1. SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB) * (C)Absence of hy...
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IPH2101 is an investigational small molecule developed by Innate Pharma S.A. (ticker IPHA) for oncology indications. It has been studied in acute myeloid leukemia, multiple myeloma, and smoldering multiple myeloma. It is an inhibitor targeting the KIR2DL3 and KIR2DL1 receptors and has completed Phase 1 clinical development.
IPH2101 has been studied in acute myeloid leukemia, multiple myeloma, and smoldering multiple myeloma. Clinical trials enrolled patients with these blood cancers, including a Phase 1 extension trial in acute myeloid leukemia patients aged 60 years and older in France, and Phase 2 studies in multiple myeloma and smoldering multiple myeloma.
IPH2101 targets KIR2DL3 and KIR2DL1, members of the killer cell immunoglobulin-like receptor family. It is classified as an inhibitor of these receptors. By targeting KIR2DL1 and KIR2DL3, the drug is designed to act on inhibitory signaling in natural killer cells, a mechanism relevant to anti-tumor immune activity.
IPH2101 is developed by Innate Pharma S.A., a biopharmaceutical company whose ticker is IPHA. Innate Pharma sponsored the clinical trials evaluating IPH2101 in acute myeloid leukemia, multiple myeloma, and smoldering multiple myeloma.
IPH2101 has completed Phase 1 clinical development. It is an investigational agent and is not approved for any indication. A Phase 1 extension trial assessed repeated dosing in acute myeloid leukemia, and two Phase 2 studies were conducted in multiple myeloma and smoldering multiple myeloma, all now completed.
IPH2101 has been evaluated in completed trials including NCT01256073, a Phase 1 safety and tolerability extension trial in acute myeloid leukemia in France; NCT01222286, a Phase 2 study in smoldering multiple myeloma in the United States; and NCT00999830, a Phase 2 study in multiple myeloma in France.