Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 human monoclonal antibody being studied for use in Acute Myeloid Leukemia, Multiple Myeloma, and Smoldering Multiple Myeloma. It is developed by Innate Pharma S.A. and has completed clinical trials in these oncology indications.
IPH2101 is a human monoclonal antibody that targets KIR (killer cell immunoglobulin-like receptors), as indicated by its alternative name Anti-KIR (1-7F9). It is being studied for its potential anti-tumor activity in hematologic malignancies.
IPH2101 is developed by Innate Pharma S.A., a biopharmaceutical company listed on the stock exchange under the ticker IPHA. The company has conducted clinical trials of IPH2101 in patients with multiple myeloma and other blood cancers.
IPH2101 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. All three clinical trials listed for IPH2101 have been completed, with no active trials currently ongoing.
IPH2101 has completed three clinical trials: NCT00999830 in multiple myeloma (Phase 2, 27 patients, France), NCT01222286 in smoldering multiple myeloma (Phase 2, 30 patients, United States), and NCT01256073 in acute myeloid leukemia (Phase 1, 21 patients, France).
Yes, IPH2101 is also known as Anti-KIR (1-7F9). The clinical trial NCT01256073 refers to IPH2101 as Anti-KIR (1-7F9) human monoclonal antibody, confirming that these names refer to the same investigational drug.