Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Phase I/II, First in Human, Dose Escalation Trial of TL-895 Monotherapy in Subjects with Relapsed/Refractory B-Cell Malignancies and Expansion of TL-895 Monotherapy and Combination Therapy with Navtemadlin in Treatment-Naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Subjects and Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma

This research is a Phase I/II clinical trial, which means it's one of the first times this new drug, TL-895, is being tested in humans. It's for adults with specific blood cancers called B-cell malignancies, chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), especially if their cancer has returned or didn't respond to earlier treatments. The study aims to find the right dose of TL-895, see how safe it is, and check how effective it is at shrinking or controlling the cancer. Some participants with CLL or SLL who haven't had treatment yet will also try TL-895, sometimes combined with another drug called Navtemadlin. Doctors will carefully monitor participants’ health and how their cancer responds.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Telios Pharma Inc., Telios Pharma Inc.

Enrolment target

Start

14 Dec 2024

B Cell Malignancies and Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

This clinical trial is designed to investigate a new medication called TL-895. It's considered a 'first-in-human' study, meaning it's one of the initial times this drug is being given to people. The study is particularly for adults diagnosed with certain types of blood cancers, specifically B-cell malignancies, chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). Many of the participants will have cancer that has either come back after treatment or hasn't responded to previous therapies.

The main goals of this study are to find out if TL-895 is safe and to determine the best dose to give. Researchers will also be looking closely to see how well the drug helps to control the cancer, such as shrinking tumors or stopping the cancer from growing. For some people with CLL or SLL who haven't had treatment before, the study will also look at TL-895 alone or in combination with another existing drug called Navtemadlin.

Ultimately, studies like this are crucial steps in finding new and potentially better ways to treat these types of cancers. By carefully observing how participants respond and how the drug behaves in the body, scientists can learn a lot that could lead to new treatments becoming available in the future.

Key takeaways

This study is testing a new drug, TL-895, for specific blood cancers.
It's for adults with B-cell malignancies, CLL, or SLL, especially if their cancer has returned or didn't respond to past treatments.
The main goals are to find a safe dose and see how well the drug controls the cancer.
For some, TL-895 might be combined with another drug, Navtemadlin.
Participation involves regular clinic visits for monitoring and assessments.
You can stop participating at any time.

Who may be eligible?

This study is open to adults aged 18 and over, regardless of their gender. Participants must have specific types of blood cancer:

* B-cell malignancies (a group of cancers that affect immune cells called B-cells). * Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). For many, their cancer will have either returned after previous treatment or not responded to it.

However, some people with CLL or SLL who haven't had treatment yet might also be eligible to join certain parts of the study. Your medical team will carefully review your health and medical history to see if this study is a good fit for you.

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 18 years old or older?
Do you have a diagnosis of B-cell malignancy, Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL)?
Has your cancer come back or not responded to previous treatments (not applicable if you have untreated CLL/SLL)?
Are you able to attend regular clinic appointments and follow study instructions?
Do you have any other serious medical conditions that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study drug, TL-895, as part of your treatment. For some people, this might be combined with another drug called Navtemadlin. You'll have regular visits to the clinic where doctors and nurses will conduct various assessments. These will include checking your general health, taking blood samples, monitoring your heart (with ECGs), and recording your vital signs (like blood pressure and pulse).

The medical team will carefully keep track of any side effects you experience to understand the safety of the drug. They will also repeatedly assess your cancer to see how it's responding to the treatment, for example, by checking if tumors are shrinking or if the cancer cells are reducing. The total duration of your participation will depend on how you respond to the treatment and the specific part of the study you are in, and your doctor will discuss this with you.

Potential risks and benefits

Taking part in a clinical trial like this offers the potential to receive a new treatment that isn't yet widely available, which might help control your cancer if other treatments haven't worked or are not an option. Your health will also be very closely monitored by a dedicated medical team. However, with any new medication, there are potential risks. The study drug could cause side effects, some of which might be serious, and we don't know the full extent of these yet. The treatment might also not work for everyone. It's important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

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

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Unverified
Hungary
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Unverified
Poland

Common questions

What is TL-895?

TL-895 is a new drug being tested for certain blood cancers. Its full effects and safety are still being studied.

What are B-cell malignancies, CLL, and SLL?

These are types of cancer that affect certain immune cells called B-cells. CLL and SLL are specific forms of these cancers.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment (relapsed) or didn't respond to previous treatments (refractory).

Will I get TL-895 or a different drug?

All participants will receive TL-895. Some people with CLL or SLL might also receive it with another drug called Navtemadlin.

How long will I be in the study?

The length of time you participate will depend on your response to the treatment. Your doctor will provide more details.