Approval Probability
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Adjusted LOA
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Also known as MP0533 monotherapy, Part 1
MP0533 · 1 trial · 4 indications
Incidence of dose limiting toxicities, assessment of toxicity/safety, pharmacokinetic and efficacy parameters
Best overall response of complete remission (CR), complete remission with partial hematological recovery (CRh), complete remission with incomplete hematological recovery (CRi), morphologic leukemia-free state (MLFS) and partial remission (PR) according to the European LeukemiaNet (ELN) response criteria 2022
| Arm | Type | Description |
|---|---|---|
| Dose escalation (Part 1) | EXPERIMENTAL | • MP0533 is administered by intravenous infusion |
| Dose escalation (Part 2 - Arm A) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered |
| Dose escalation (Part 2 - Arm B) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional Obinutuzumab pretreatment administered |
| Dose expansion (Arm A) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion at densified dosing schedule * Obinutuzumab pretreatment administered |
| Dose expansion (Arm B relapsed/refractory AML) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional Obinutuzumab pretreatment administered |
| Dose expansion (Arm B in treatment naïve patients) | EXPERIMENTAL | * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered |
| Name | Type | Description |
|---|---|---|
| MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 1 | DRUG | MP0533 is administered by intravenous infusion |
| MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) monotherapy, Part 2-Arm A | DRUG | * MP0533 is administered by intravenous infusion * Obinutuzumab pretreatment administered |
| MP0533 (multispecific DARPin CD3 Engager Targeting CD33, CD123 and CD70) + azacitidine + venetoclax | DRUG | * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered |
| MP0533 with Obinutuzumab pretreatment | DRUG | * MP0533 is administered by intravenous infusion at densified dosing schedule * Obinutuzumab pretreatment administered |
| MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B relapsed/refractory AML | DRUG | * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered |
| MP0533 + azacitidine + venetoclax with optional Obinutuzumab pretreatment, Arm B in treatment naïve patients | DRUG | * MP0533 is administered by intravenous infusion * Azacitidine is administered by subcutaneous injection for 7 days per cycle * Venetoclax is administered orally for 14 days per cycle * Optional obinutuzumab pretreatment administered |
Inclusion Criteria: * Has signed and dated written informed consent prior to performing any study procedure, including screening * Diagnosis of relapsed/refractory AML or relapsed/refractory MDS/AML according to the ELN recommendation 2022. * Age ≥18 years old on the day of signing informed consent...
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