CX-5461 for Advanced Solid Tumors with Specific Genetic Mutations

This study is testing a drug called CX-5461 in people with advanced solid tumors, specifically those affecting the pancreas, prostate, breast, or ovary. To join, you must have a specific genetic change (mutation) in BRCA1/2, PALB2, or other genes related to Homologous Recombination Deficiency (HRD). The main goal is to find a safe and tolerable dose of CX-5461 for future studies. Researchers will also look at how well CX-5461 works against the cancer and its effects on your quality of life. CX-5461 works by targeting cancer cells that have these specific genetic changes. The study plans to enroll 52 participants, but its current status is unclear.

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know you are receiving CX-5461. It aims to enroll 52 participants.
What's involved
CX-5461 is given by IV infusion on Day 1 and Day 8 of a 28-day cycle. Safety will be reviewed every 4 weeks until all patients are enrolled and evaluated for toxicity.
Compensation
Not stated in the trial record.
Follow-up
Safety data will be reviewed every 4 weeks from the date of the first patient's enrollment until all patients have been enrolled and evaluated for toxicity.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04890613

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Senhwa Biosciences, Inc.
~52 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:CX-5461

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of Recommended Phase 2 Dose (RP2D)
Measured over Safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity.
Advanced Solid Tumor
8 sites across 8 states
California1
Florida1
Massachusetts1
New York1
Ohio1
Pennsylvania1
Ontario1
Quebec1
  • Jason Huang, MD · STUDY_DIRECTOR · Senhwa Biosciences

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  • Determination of Recommended Phase 2 Dose (RP2D)Safety cohort review will be conducted every 4 weeks from the date of first patient's enrollment to review safety data, until all patients have been enrolled and evaluated for toxicity.

    To identify the number of patients who discontinue study drug due to toxicity for each of the two dosing regimens independently.