A Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies (CASSANDRA)
The main aims of this 2-part study are: * Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL). * Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).
• Age ≥18 years
• Performance status (ECOG) ≤ 2
• Life expectancy ≥3 months
• Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
• Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
• Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments.
• Adequate hematological or biochemical parameters as specified below
‣ Hemoglobin \> 8.0 g/dl (without transfusion support within 7 days)
⁃ Platelets count \> 75 x109/L (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109/L.
⁃ Absolute neutrophil count (ANC) \> 0.75 x109/L (without G-CSF support within 7 days)
⁃ Aspartate transaminase (AST): \<2.5 x the upper limit range (in patients with no liver metastases or \<5 x ULN in patients with liver metastases)
⁃ Alanine transaminase (ALT): \< 2.5 x the upper limit range (in patients with no liver metastases or \<5 x ULN in patients with liver metastases)
⁃ Total bilirubin: \< 2 x the upper limit range.
⁃ Calculated or measured creatinine clearance: \>30 mL/min (calculated from the Cockcroft-Gault formula).
• Left ventricular ejection fraction \> 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.