Senhwa Biosciences, Inc. Stand Up To Cancer (SU2C) Canada - Canadian Breast Cancer Foundation Grant
Estimated Enrollment
40-60 patients with solid tumors for Dose Escalation stage. 10-20 patients with metastatic breast cancer for Expansion stage
Objective
Phase I Escalation (Solid tumors)
Primary Objective:
To determine the recommended phase II dose (RP2D) and schedule of CX-5461 in patients with solid tumors.
Secondary Objective:
To establish the safety and tolerability of CX-5461 given intravenously to patients with solid tumors.
To determine the pharmacokinetics of CX-5461 given intravenously in patients with solid tumors.
Phase I Expansion: (Breast cancer)
Primary Objective:
To explore the relationship between germline HRD (homologous recombination deficiency) aberrations and outcomes of CX-5461, including efficacy and toxicity.
To evaluate CX-5461 drug levels in skin and tumor.
To evaluate biomarkers of response to CX-5461
using ctDNA (all patients after Amendment #3);
paired biopsies (all patients after Amendment #3);
paired tumour biopsies (mandatory for 6-8 patients at RP2D)
