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Study identifier: NCT04890613 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Advanced Solid Tumor  ·  Sponsor: Senhwa Biosciences, Inc.

PhasePhase 1
Planned participants52
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Hylee Lee  ·  886-2-889119856  ·  hylee@senhwabio.com

Jenny Chen  ·  jennychen@senhwabio.com

Always discuss trial participation with your own doctor first.

Locations (8)

University of California, Los AngelesSanta Monica, California, United StatesRecruiting
H. Lee Moffitt Cancer Center and Research Institute HospitalTampa, Florida, United StatesRecruiting
Dana Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
Memorial Sloan-Kettering Cancer CenterNew York, New York, United StatesWithdrawn
Ohio State University-James Cancer Hospital and Solove Research InstituteColumbus, Ohio, United StatesRecruiting
UPMC Hillman Cancer CenterPittsburgh, Pennsylvania, United StatesRecruiting
Princess Margaret Cancer CentreToronto, Ontario, CanadaRecruiting
Centre hospitalier de l'Université de Montréal (CHUM)Montreal, Quebec, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT04890613