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.
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
At a glance
Conditions
Where it's being run
8 sites across 8 statesStudy leadership
- Jason Huang, MD · STUDY_DIRECTOR · Senhwa Biosciences
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.