RecruitingPHASE1INTERVENTIONAL

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

This study is testing a new treatment called CX-5461 for people with advanced solid tumours that have certain genetic changes, such as in the BRCA1 or BRCA2 genes. It's a 'Phase 1b' trial, meaning researchers want to find the best and safest dose of CX-5461 to use in future studies. The drug is given directly into a vein. They'll also be watching to see if the drug has any positive effects on the cancer and how it affects patients' overall quality of life. This research is important for understanding how this new treatment works and who it might help most in the future.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Senhwa Biosciences, Inc.

Enrolment target

Start

08 Sep 2021

Estimated completion

01 Mar 2027

Advanced Solid Tumor

What is this study about?

This study is about a new drug called CX-5461, which is being tested for people with advanced solid tumours. Advanced means the cancer has grown or spread. The key thing is that participants in this study will have specific changes in certain genes, like BRCA1, BRCA2, or others linked to how the body repairs damaged DNA. These gene changes are sometimes found in cancers of the pancreas, prostate, breast, or ovary.

The drug, CX-5461, works by targeting cancer cells that have trouble repairing their DNA, leaving healthy cells alone as much as possible. Researchers want to find the right amount of CX-5461 to give that is both safe and effective. They will give the drug through a drip into a vein on certain days of a 28-day cycle. They will carefully check for any side effects and see if the drug helps to shrink the tumours or stop them from growing.

Another important part of this study is understanding how the treatment affects patients' everyday lives. This means looking at their quality of life, including how they feel and their ability to do daily activities. By carefully studying patients with these particular gene changes, researchers hope to learn more about how CX-5461 works and if it could be a useful treatment option for certain cancers in the future.

Key takeaways

New drug (CX-5461) for advanced solid tumours.
Specifically for cancers with certain gene changes (e.g., BRCA1/2).
Aims to find the safest dose and check for anti-cancer effects.
Involves regular clinic visits and tests.
Could help understand new treatments for these cancers.
Your quality of life will be monitored throughout.

Who may be eligible?

To join the main part of this study, you would need to have certain advanced solid tumours, specifically in the pancreas, prostate, breast, or ovary. A crucial requirement is having a confirmed change (mutation) in specific genes, such as BRCA1, BRCA2, or PALB2, or other related genes that affect how your body repairs DNA. This gene change must be identified by a special lab test.

There's also a smaller group within the study, called an 'exploratory cohort,' specifically for people with certain types of ovarian, fallopian tube, or primary peritoneal cancer. For this group, you'd also need to have a specific gene change. Additionally, for this smaller group, your cancer would need to be either sensitive to platinum-based chemotherapy (meaning it responded well and hasn't progressed for at least 6 months), or resistant to it (meaning it progressed within 6 months of the last dose).

Finally, for all parts of the study, you must be at least 18 years old. Your general health and fitness, measured by something called an ECOG score, also needs to be at a certain level to ensure you can safely take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have an advanced solid tumour (pancreas, prostate, breast, or ovary)?
Have I had a genetic test showing changes in genes like BRCA1, BRCA2, or PALB2?
Am I at least 18 years old?
If I have ovarian, fallopian tube, or primary peritoneal cancer, is it high-grade serous or endometrioid?
Am I generally well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the drug CX-5461 through a drip into your vein on Day 1 and Day 8 of each 28-day cycle. You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will carefully record any side effects you experience. Your quality of life will also be assessed through questionnaires. The total duration of your participation will depend on how you respond to the treatment and the study's monitoring schedule, but you will be closely followed throughout.

Potential risks and benefits

Participating in this study might offer a potential benefit by providing access to a new experimental drug, CX-5461, which could help your cancer, especially if other treatments haven't worked or aren't suitable. However, as with any new treatment, there are potential risks, including unknown side effects or that the drug may not be effective for your cancer. The research team will monitor you closely for any side effects. You are always free to withdraw from the study at any time for any reason without it affecting your usual medical care.

Locations (8)

University of California, Los Angeles
Verified postcode
Santa Monica, United States· Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital
Verified postcode
Tampa, United States· Recruiting
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Memorial Sloan-Kettering Cancer Center
Verified postcode
New York, United States· Withdrawn
Ohio State University-James Cancer Hospital and Solove Research Institute
Verified postcode
Columbus, United States· Recruiting
UPMC Hillman Cancer Center
Verified postcode
Pittsburgh, United States· Recruiting
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada· Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What kind of cancer is this study for?

This study is for advanced solid tumours in the pancreas, prostate, breast, or ovary, and also for specific types of ovarian, fallopian tube, or primary peritoneal cancer.

What does a 'gene mutation' mean?

A gene mutation means there's a change in the genetic code of your cancer cells, like in the BRCA1 or BRCA2 genes, which can sometimes make the cancer respond differently to treatments.

How is the study drug given?

The study drug, CX-5461, is given as a drip directly into a vein on two specific days during each 28-day treatment cycle.

What is 'Phase 1b'?

Phase 1b means it's an early-stage study focusing on finding the safest and most effective dose of a new drug, and seeing how best to give it, for future, larger studies.

Will I know if the drug is working?

The study team will perform regular scans and tests to monitor your cancer and will discuss the results with you, so you'll be informed about how the treatment is progressing.

How to find out more

Hylee Lee

hylee@senhwabio.com 886-2-889119856 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.