Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation

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

Trial Details

NCT ID
NCT04890613
Phase
PHASE1
Sponsor
Senhwa Biosciences, Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • CX-5461
Locations (sample)
  • Santa Monica, California, United States|34.01949,-118.49138
  • Tampa, Florida, United States|27.94752,-82.45843
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • New York, New York, United States|40.71427,-74.00597
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Main study cohort:
  • Histologically or cytologically confirmed malignancy of the pancreas, prostate, breast, or ovary.
  • Documented evidence of pathogenic or likely pathogenic somatic or germline mutation in BRCA1/2 and/or PALB2, and/or any genetic alterations listed …
  • ATM, ATR, BARD1, BRCA1, BRCA2, BRIP1, CCNE1, CHEK1, CHEK2, CDK12, CREBBP, FANCA, FANCI, FANCL, FANC2, FANCB, FANCC, FANCD2, FANC family\*, MRE11A, …

For full eligibility, visit ClinicalTrials.gov.

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