BCC021 Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors
Objective
Phase I Primary Objectives: To characterize the safety profile of silmitasertib in combination with chemotherapy. To determine the Recommended Phase 2 Dose (RP2D) of silmitasertib in combination with chemotherapy.
Phase I Secondary Objectives: To describe the pharmacokinetics of silmitasertib in combination with chemotherapy. To evaluate the preliminary anti-tumor activity of silmitasertib in combination with chemotherapy based on: Overall Response Rate (ORR), Progression Free Survival (PFS).
Phase II Primary Objective: To evaluate silmitasertib in two separate disease cohorts based upon Overall Response Rate (ORR): Cohort 1: Relapsed/refractory Neuroblastoma, Cohort 2: Relapsed/refractory Ewing Sarcoma
Phase II Secondary Objectives: To evaluate the efficacy of silmitasertib in disease cohorts outlined above, based upon: Progression Free Survival (PFS), Overall Survival (OS). To evaluate the safety and tolerability profile of silmitasertib in pediatric and young adult subjects with solid tumors.
