CX-5461-Solid Tumors and BRCA2 and/or PALB2 mutation
Study Focus
CX-5461-Solid Tumors and BRCA2 and/or PALB2 mutation
Protocol Number
CX-5461-04
Sponsor
Senhwa Biosciences, Inc.
Estimated Enrollment
52 patients • Main study - 32 patients • Exploratory study -20 patients
Objective
Primary Objective:
To determine the recommended phase II dose (RP2D)
Secondary Objective:
To assess the safety and tolerability, e.g. late onset toxicity (ocular toxicity)
To evaluate the anti-tumour activity in patients with solid tumours and germline BRCA2 and/or PALB2
To evaluate the effect on Health Related Quality of Life (HRQoL) - using Patient Reported Outcomes
Exploratory Objective:
To evaluate the anti-tumour activity of CX-5461 in patients with ovarian cancer and pathogenic/likely pathogenic BRCA1 mutation and/or other HRD-associated somatic mutation.
To characterize the molecular profile of tumours and evaluate predictive value of mutational signatures (including BRCA 1/ 2, PALB2, and other HRD-associated somatic mutations) in predicting response or resistance to CX-5461.
To explore the significance of dynamic changes in ctDNA levels and plasma DNA
