RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

This research study is investigating a new medication called Tulmimetostat (also known as DZR123 or CPI-0209) for adults battling advanced cancers, including certain solid tumours and lymphomas. It's being carried out in two main parts, Phase 1 and Phase 2. In Phase 1, the focus is on finding the safest and most effective dose of Tulmimetostat when given on its own. Researchers will carefully watch for any side effects and how well patients tolerate the medicine. Phase 2 then looks at how safe and effective Tulmimetostat is in specific types of cancer. For some patients, it will test Tulmimetostat by itself, and for others, it might be given alongside an existing medicine called Enzalutamide. The overall aim is to see if this new treatment can help manage these advanced cancers.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

275

Start

18 Sep 2019

Estimated completion

27 Feb 2030

Advanced Solid Tumor Diffuse Large B Cell Lymphoma Lymphoma, T-Cell Mesothelioma, Malignant Prostatic Neoplasms, Castration-Resistant Endometrial Cancer Ovarian Clear Cell Carcinoma Metastatic Castration-resistant Prostate Cancer

What is this study about?

This research study is exploring a new medicine called Tulmimetostat (you might also see it as DZR123 or CPI-0209) that could potentially help people with various advanced cancers. These include certain solid tumours that have spread, different types of lymphoma (which are cancers of the immune system), and specific cancers like mesothelioma, prostate cancer (that hasn't responded to other treatments), endometrial cancer, and a type of ovarian cancer.

The study is divided into two main stages, called Phase 1 and Phase 2. Phase 1 is like the initial testing stage, focusing on finding the right amount of Tulmimetostat to give to patients. Doctors will start with a small dose and gradually increase it, always making sure it's as safe as possible and checking for any side effects. The goal is to discover the best dose that patients can handle well.

Once the safest dose is identified, the study moves into Phase 2. Here, the research will look more closely at how well Tulmimetostat works against specific types of cancer. For some patients, Tulmimetostat will be given on its own, and for others, it might be tested alongside another treatment called Enzalutamide, especially for prostate cancer. The overall aim is to understand if Tulmimetostat can shrink tumours or stop them from growing, and to continue monitoring its safety.

Key takeaways

Tests a new medicine, Tulmimetostat, for advanced cancers.
Checks safety, side effects, and if it helps control cancer.
For specific advanced solid tumours and lymphomas.
May involve Tulmimetostat alone or with Enzalutamide.
Participation requires regular check-ups and monitoring.

Who may be eligible?

To join this study, generally, you need to be an adult with a confirmed advanced cancer, either a solid tumour or a type of lymphoma, that hasn't responded well to standard treatments, or where no other good treatments are available.

For some parts of the study, specifically for patients with certain solid tumours, ovarian cancer, or endometrial cancer, doctors will need to check if your cancer has a particular genetic change called an ARID1A mutation. Also, the cancer needs to be actively measurable using scans.

If you have a type of lymphoma (either PTCL or DLBCL), you would need to have already tried a certain number of other treatments. For prostate cancer, you'd need to have a specific type that hasn't responded to previous hormone therapy or chemotherapy. For mesothelioma, you'd also need to have tried at least one earlier treatment.

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 aged 18 or over?
Do you have an advanced solid tumour or lymphoma?
Has your cancer progressed on standard treatments, or are there no other good options?
Are you able to attend regular clinic visits and appointments?
For some cancers, has your doctor confirmed specific genetic changes (like ARID1A mutation)?

Answer every question to see your result.

What does participation involve?

The study involves taking either the new medicine, Tulmimetostat, on its own or sometimes alongside Enzalutamide. Your participation will involve regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. Some parts of the study might involve deciding randomly which dose or combination of medicines you receive. The exact number of visits and the total length of your participation will depend on which part of the study you're in and how you respond to the treatment, but visits will be regular, and you'll be closely monitored throughout.

Potential risks and benefits

Because this is a new medicine, there might be unknown side effects, and some patients might experience unpleasant reactions to the treatment. The research team will monitor you closely for any potential risks. While there's no guarantee, a potential benefit could be that Tulmimetostat helps to shrink your tumour or control its growth, especially if other treatments haven't worked well. You are always in control of your participation and can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (60)

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

Winship Cancer Institute of Emory University
Verified postcode
Atlanta, United States· Recruiting
University of Chicago Medical Center
Verified postcode
Chicago, United States· Recruiting
University of Maryland - Marlene and Stewart Greenebaum Cancer Center
Verified postcode
Baltimore, United States· Withdrawn
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
University of Michigan Hospital
Verified postcode
Ann Arbor, United States· Withdrawn
South Texas Accelerated Research Therapeutics (Start) - Midwest Location
Verified postcode
Grand Rapids, United States· Recruiting
Hackensack University Medical Center
Verified postcode
Hackensack, United States· Recruiting
NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center
Verified postcode
New York, United States· Recruiting
Weill Medical College of Cornell University
Verified postcode
New York, United States· Withdrawn
Montefiore Einstein Center for Cancer Care
Verified postcode
The Bronx, United States· Withdrawn
University of Cincinnati Medical Center
Verified postcode
Cincinnati, United States· Withdrawn

Common questions

What is Tulmimetostat?

Tulmimetostat is a new experimental drug being investigated to treat certain advanced cancers.

What is the main goal of this study?

The main goal is to find out if Tulmimetostat is safe, what side effects it has, and if it can help treat advanced cancers.

Will I have to pay to be in the study?

No, you will not have to pay for the study medication or procedures related to the study.

Can I continue with my normal activities during the study?

The study team will discuss any potential restrictions on your activities with you based on your health and the treatment plan.

What if the study treatment doesn't work for me?

If the treatment isn't working or your condition worsens, the study team will discuss other treatment options with you and ensure you receive appropriate care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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