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

Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies

This research study is looking at a new medicine called TransCon TLR7/8 Agonist for adults with advanced or metastatic cancer. It's in the early stages (Phase 1 and 2), meaning it's one of the first times this medicine is being given to people. Some patients will receive the new medicine by itself, while others will have it alongside an existing cancer treatment called Keytruda. The main goals are to find a safe and effective dose, understand any side effects, and see if the treatment can help shrink tumours or stop them from growing. Researchers will also look at how the body handles the new drug. This type of study helps us learn if new treatments can be helpful for people with cancer.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

Ascendis Pharma Oncology Division A/S

Enrolment target

Start

03 Oct 2024

Cancer

What is this study about?

This study is designed to explore a new potential cancer treatment called TransCon TLR7/8 Agonist. It's for adults who have cancer that has spread or is advanced. The aim is to see how safe this new medicine is, what side effects it might cause, and to find the best dose to give. Sometimes, new treatments are more effective when combined with others, so some participants will also receive an established cancer drug called Keytruda.

This is an early-stage study, known as Phase 1 and Phase 2. In Phase 1, the main focus is on safety and finding the right dose. In Phase 2, researchers look more closely at how well the treatment works against cancer. By combining these phases, scientists can learn faster. They will be carefully monitoring participants for any changes in their health and how their tumours respond.

The information gathered from this study is really important. It helps doctors understand if this new medicine has the potential to become a future treatment option for people with advanced cancer. Every step in cancer research, like this study, brings us closer to better ways to manage and treat the disease.

Key takeaways

This study is testing a new cancer medicine, alone or with Keytruda, for advanced cancers.
It's an early-stage study (Phase 1/2) focused on safety and finding the right dose.
Researchers will closely monitor side effects and how tumours respond.
You must be over 18 with locally advanced or metastatic solid tumour cancer to be considered.
Participation involves regular clinic visits, blood tests, scans, and receiving study medication.
You can withdraw from the study at any time without affecting your ongoing care.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for adults who have been diagnosed with cancer that is either locally advanced (meaning it has grown into nearby tissues) or metastatic (meaning it has spread to other parts of the body).

There will be other, more detailed requirements that the study doctors will check to make sure the treatment is suitable and safe for you. These might include your general health, past treatments you've had, and specific characteristics of your cancer.

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 locally advanced or metastatic solid tumour cancer?
Are you able to travel to the study clinic for regular appointments?
Are you comfortable with receiving an investigational (new) medicine?
Have you discussed your interest in clinical trials with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have regular visits to the clinic. These visits will involve various checks, such as blood tests, physical examinations, and scans (like CT or MRI scans) to see how your body is responding to the treatment and if your tumour is changing. You will receive one or both of the study medications, TransCon TLR7/8 Agonist and/or Keytruda, usually given as injections or infusions (into a vein).

The full duration of your participation will depend on how you respond to the treatment and whether you experience any side effects. You will be closely monitored throughout and after your treatment period. The study team will explain everything in detail, including how long each visit might be and the overall commitment required.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help your cancer. However, there are also potential risks, as the new medicine might cause side effects that are currently unknown or more severe than expected. The doctors will monitor you very closely for any issues. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care. The study team will discuss all known potential risks and benefits with you in detail before you make a decision.

Locations (2)

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

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Unverified
Spain
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Unverified
Netherlands

Common questions

What is 'advanced or metastatic solid tumour malignancies'?

This refers to cancer that has either grown into nearby parts of the body (advanced) or has spread from where it started to other areas (metastatic). 'Solid tumour' means it started as a lump or growth, not a blood cancer like leukaemia.

What is a 'Phase 1/2' study?

It's an early-stage study. Phase 1 focuses on finding a safe dose and understanding side effects. Phase 2 then looks at how well the treatment works. This study combines both, helping researchers learn faster.

What does 'open-label' mean?

This means that both you and your study doctor will know which treatment you are receiving (the new drug, or the new drug with Keytruda). Nobody is 'blinded' to the treatment.

What are 'side effects' and 'dose-limiting toxicities'?

Side effects are any unwanted effects from the treatment. Dose-limiting toxicities are side effects that are severe enough to require lowering the dose or stopping the treatment in future patients.

What is Keytruda?

Keytruda is an existing cancer medicine that works by helping your body's immune system fight cancer cells. It's often used for various types of advanced cancer.