drugset / Trial / NCT05908409

A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies

NCT05908409 ↗

Phase 1/2 Recruiting 37 enrolled IDP Discovery Pharma S.L.
Non-randomizedSequentialOpen-labelTreatment

Summary

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).

Timeline

Start
2023-06-05
Primary completion
2025-12-22
Completion
2026-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject IDP-121 Unknown 0.015 mg/kg Intravenous
Subject IDP-121 Unknown 0.032 mg/kg Intravenous
Subject IDP-121 Unknown 0.7 mg/kg Intravenous