RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

This study is looking into a new drug called HLD-0915 for men who have prostate cancer that has spread and is no longer responding to hormone therapy. This type of cancer is known as metastatic castration-resistant prostate cancer (mCRPC). The main goals are to find out if HLD-0915 is safe to use, how well it's tolerated by patients, and if it can help stop the cancer from growing. Researchers also want to figure out the best dose of the drug. Patients chosen for the study would have already tried other treatments that haven't worked or have stopped working for their cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Halda Therapeutics OpCo, Inc.

Enrolment target

Start

24 Feb 2025

Estimated completion

01 Mar 2027

Prostate Cancer Metastatic Disease Prostate Cancer (Adenocarcinoma)

What is this study about?

This research study is about a new drug, HLD-0915, for men with a type of advanced prostate cancer. This is prostate cancer that has spread to other parts of the body (metastatic) and is no longer being controlled by hormone treatments (castration-resistant). These men have usually already tried other medicines for their condition.

The study has two main parts. In the first part, called Phase 1, the researchers will give different doses of HLD-0915 to a small number of patients to find the safest and most effective dose. This helps them understand how much of the drug the body can handle and if there are any side effects. In the second part, called Phase 2, a larger group of patients will receive the chosen dose to further check how well the drug works against the cancer and to gather more information about its safety.

The aim of the entire study is to see if HLD-0915 can be a helpful new treatment option for men with this challenging form of prostate cancer. Researchers will be looking at whether the drug can slow down the cancer's growth and improve patients' health.

Key takeaways

This study is testing a new oral drug, HLD-0915, for advanced prostate cancer.
It's for men whose cancer has spread and stopped responding to hormone therapy.
The study aims to check the drug's safety and how well it works.
Participants will continue their current hormone therapy if applicable.
Regular monitoring includes blood tests and scans.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be a man aged 18 or older with prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy. You would have already received other treatments for your cancer that have either stopped working or were not successful. Your prostate cancer must be confirmed as adenocarcinoma, and you need to be able to take medication by mouth. Overall, you should be in reasonably good health, able to move around independently (or with a little help), and expected to live at least another three months.

However, there are also reasons why you might not be able to join. For example, if you've recently had a serious bleed or have a known bleeding problem, or if your cancer is a specific rare type. You also can't be taking high doses of certain steroid medications. There are also rules about how recently you've had other cancer treatments or been part of other research studies.

Your study doctor will carefully review all your medical information to see if this study is suitable for you. They will explain all the requirements in detail.

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.

Are you a man aged 18 or older?
Do you have prostate cancer that has spread?
Has your prostate cancer stopped responding to hormone treatment?
Have you already tried other treatments for your prostate cancer?
Can you swallow medication by mouth?
Are you generally in good health with no major bleeding problems or recent heart issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the experimental drug HLD-0915, which you will take by mouth. You will continue to receive your usual hormone therapy unless you have already had surgery to remove your testicles. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits are important for the researchers to understand the drug's effects. The study will last for an unspecified period as long as the drug is benefiting you and you are tolerating it well, with regular follow-up appointments even after you stop taking the study drug.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. While HLD-0915 is still being investigated, there's a chance it could help slow down your prostate cancer, which would be a direct benefit to you. However, like all medications, HLD-0915 may cause side effects, some of which could be serious. The study team will carefully monitor you for any problems. You will be given full details of known and potential side effects before you decide to join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sarah Cannon Research Institute at HealthONE
Verified postcode
Denver, United States· Recruiting
Yale - New Haven Hospital - Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Florida Cancer Specialists
Verified postcode
Sarasota, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
START Midwest, LLC
Verified postcode
Grand Rapids, United States· Recruiting
Evelyn H. Lauder Breast and Imaging Center (BAIC)
Verified postcode
New York, United States· Recruiting
Carolina Urologic Research Center, LLC
Verified postcode
Myrtle Beach, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
NEXT Austin
Verified postcode
Austin, United States· Recruiting
The University of Texas M.D. Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
Royal Marsden Hospital
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What type of cancer is this study for?

This study is for men with prostate cancer that has spread to other parts of the body and is no longer responding to standard hormone treatments.

What is HLD-0915?

HLD-0915 is a new drug being tested to see if it can help treat advanced prostate cancer.

Will I still take my regular hormone therapy?

Yes, if you are currently on hormone therapy (Androgen Deprivation Therapy), you will continue to take it during the study unless you have had surgical removal of your testicles.

How long will the study last for me?

The study duration will vary for each person. You will continue treatment as long as it is helping you and you are not experiencing severe side effects.

What does 'Phase 1/2' mean?

Phase 1 is where researchers test different doses to find the safest one and check for side effects. Phase 2 then looks at how well that chosen dose works and gathers more safety information.

How to find out more

Medical Monitor

prostateclinicaltrial@haldathera.com 475-273-6214 Official trial record

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