Phase I clinical trial - Phases précoces tumeurs solides

CC-95775-ST-001
Phases précoces tumeurs solides
Ouvert depuis le: 10.22.2020
Site: Paris
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A PHASE 1B DOSE ESCALATION, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC AND PHARMACODYNAMIC OF CC-95775 IN SUBJECTS WITH ADVANCED SOLID TUMORS AND RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA
Description de l'essai

CC-95775-ST-001 is an open-label, Phase 1B, dose escalation and expansion study of CC-95775 in subjects with advanced or unresectable solid tumors, including laBCC, and relapsed/ refractory non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-95775 administered on a 4d on/24d off schedule to estimate the MTD of CC-95775. A mTPI-2 will help guide CC-95775 dose escalation decisions with the final decisions made by an SRC. Approximately 20 subjects will be enrolled.;The expansion cohort (Part B) will evaluate the safety, PK, PD safety and preliminary activity of CC-95775 in advanced solid tumors, including laBCC. Approximately 20 subjects will be enrolled.