Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
Status:
Recruiting
Trial end date:
2025-09-30
Target enrollment:
Participant gender:
Summary
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of
CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with
selected solid tumours and associated mutations for future Phase II trials. The safety and
tolerability of CX-5461, preliminary evidence of antitumor effect and the effect of CX-5461
on the Health-Related Quality of Life (HRQoL) will also be evaluated. The study will also
evaluate the predictive value of mutational signatures and explore the significance of
dynamic changes in ctDNA levels and plasma DNA methylome profiling in this study's
exploratory cohort.