An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
This study, called TulmiSTAR-01, is for men with prostate cancer that has spread and is no longer responding to standard hormone therapy (called metastatic castrate-resistant prostate cancer, or mCRPC). We're testing a new treatment that combines two investigational drugs, tulmimetostat and JSB462. The study is split into two main parts. First, we'll find the safest and most effective dose of these two drugs when used together. Then, we'll compare this new combination treatment against the standard care that patients usually receive. We want to see if the new combination of drugs can help control the cancer better and reduce certain markers in the blood, like PSA levels, compared to current treatments. This research aims to find better options for men facing this challenging form of prostate cancer.
At a glance
What is this study about?
This study, known as TulmiSTAR-01, is designed to investigate a new treatment approach for men with a type of prostate cancer that has spread to other parts of the body (metastatic) and is no longer responding to hormone therapy (castrate-resistant). This can be a challenging form of cancer to treat, so researchers are always looking for new and more effective options.
The study involves two new drugs, tulmimetostat and JSB462, which are being tested in combination. The main goal is to find out if this new combination is safe to use and if it can help slow down or stop the progression of the cancer. The study will also compare the effectiveness of this new combination to the standard treatments currently available for this condition. By understanding how well these new drugs work, and at what dose, we hope to offer better choices for patients in the future.
The study is being conducted in two main phases. The first phase focuses on carefully increasing the doses of the drugs to find the safest and most effective amount to give. Once the best dose is found, the second phase will compare this new combination treatment directly with the standard of care. This comparison will help determine if the new drugs offer a significant benefit, particularly by looking at how they impact a blood marker called PSA, which can indicate how the cancer is responding.
Key takeaways
- This study explores a new combination treatment (tulmimetostat + JSB462) for advanced prostate cancer.
- It's for men whose prostate cancer has spread and is no longer responding to hormone therapy.
- The study aims to find the safest dose and then compare it to standard care.
- Participants will have regular clinic visits, blood tests, and scans.
- Potential benefits include access to new drugs; potential risks involve side effects.
- Participation is voluntary, and you can leave the study at any time.
Who may be eligible?
To be considered for this study, you must be an adult man, at least 18 years old, and have prostate cancer that has been confirmed by a doctor. Your cancer must have spread to other parts of your body (metastatic) and should no longer be responding to hormone therapy.
You should have already tried at least one type of strong hormone pills (like abiraterone or enzalutamide) and your cancer should have worsened despite this treatment. If you are in the later part of the study, you shouldn't have received certain types of chemotherapy for your metastatic castrate-resistant prostate cancer, but prior chemotherapy for earlier stages of prostate cancer might be allowed.
There are also some reasons why you might not be able to join. For example, if you've already taken similar types of experimental drugs that work in a similar way to the ones being tested in this study, or if you're allergic to any of the study medications. You also shouldn't have been treated with any other experimental drug within 28 days (or five 'half-lives' of the drug, whichever is longer) before starting the study.
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 an adult man, at least 18 years old?
- Has your prostate cancer spread to other parts of your body?
- Is your prostate cancer no longer responding to hormone therapy?
- Have you previously used at least one strong hormone drug (like abiraterone or enzalutamide)?
- Have you avoided certain types of chemotherapy for your current advanced prostate cancer (if applicable to the study phase)?
- Have you avoided other similar experimental drugs in the past?
What does participation involve?
If you decide to participate in this study, you will have regular visits to the clinic for check-ups and medical tests. These may include blood tests to monitor your general health and specific markers like PSA, as well as scans (like CT, MRI, or bone scans) to see how your cancer is responding to treatment. You will be given the study medication (tulmimetostat and JSB462) to take. The first part of the study involves carefully finding the right dose, so your dose might change during this initial period. The study team will explain exactly how to take the medication.
Throughout the study, you will be closely monitored for any side effects. There will be scheduled follow-up visits and assessments to track your progress. The total duration of your participation will depend on how you respond to the treatment and the phase of the study you are in, but it will involve ongoing monitoring and regular clinic visits.
Potential risks and benefits
Locations (32)
- Sarah Cannon Research InstituteVerified postcodeDenver, United States· Recruiting
- Sarah Cannon Research InstituteVerified postcodeJacksonville, United States· Recruiting
- Emory UniversityVerified postcodeAtlanta, United States· Recruiting
- Wichita Urology Group PAVerified postcodeWichita, United States· Recruiting
- Mass General HospitalVerified postcodeBoston, United States· Recruiting
- Fred Hutchinson Cancer Research CenterVerified postcodeSeattle, United States· Recruiting
- Novartis Investigative SiteVerified postcodeSt Leonards, Australia· Recruiting
- Novartis Investigative SiteVerified postcodeMelbourne, Australia· Recruiting
- Novartis Investigative SiteVerified postcodeLiverpool, Australia· Recruiting
- Novartis Investigative SiteVerified postcodeHalifax, Canada· Recruiting
- Novartis Investigative SiteVerified postcodeBeijing, China· Recruiting
- Novartis Investigative SiteVerified postcodeHerlev, Denmark· Recruiting
Common questions
What is 'metastatic castrate-resistant prostate cancer'?
This is prostate cancer that has spread to other parts of the body (metastatic) and has stopped responding to standard hormone treatments (castrate-resistant).
What are tulmimetostat and JSB462?
These are the names of two new investigational drugs being tested in this study. They are not yet approved for general use but are being researched for their potential to treat prostate cancer.
Will I definitely get the new drugs, or could I get standard treatment?
In the initial phase, you will receive the new combination. In the later phase, some participants will receive the new combination, while others will receive standard care, so they can be compared.
What does 'taxane-naive' mean?
It means you have not previously received a type of chemotherapy drug called a 'taxane' for your metastatic castrate-resistant prostate cancer.
How long will I be in the study?
The duration varies. You'll be closely monitored as long as the treatment is beneficial and you meet the study requirements. The study team will provide more specific details.
How to find out more
Novartis Pharmaceuticals
Always speak to your GP or specialist before deciding to take part in a study.
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