Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia

Titre officiel

A Phase 1, Multi-centre, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Sommaire:

This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

Description de l'essai

Primary Outcome:

• Dose limiting toxicities (DLTs)
• Maximum tolerated dose (MTD)
• Adverse Events (AEs)

• Complete remission rate (CRR)
• Objective response rate (ORR)
• Progression-free survival (PFS)
• Overall survival (OS)
• Pharmacokinetics - Cmax
• Pharmacokinetics - AUC
• Pharmacokinetics - tmax
• Pharmacokinetics - t1/2
• Pharmacokinetics - CL
• Pharmacokinetics - Vss
• Presence of anti-drug antibodies (ADA)
• Frequency of anti-drug antibodies (ADA)

Voir cet essai sur ClinicalTrials.gov