Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

An open-label, multicenter Phase 1/2 dose escalation and expansion study of THOR-707 as a single agent and as a combination therapy in adult subjects with advanced or metastatic solid tumors

This research study, called THOR-707, is looking into a new medicine for adults with advanced or spreading cancer. It's an early-stage study, meaning we're still learning a lot about the medicine. The main goals are to find the best and safest dose of THOR-707, and to see if it helps control the cancer when given by itself or with other treatments. Researchers will also closely monitor any side effects. To make sure participants are comfortable during the study, they might receive other medicines like those for allergies (DIPHENHYDRAMINE), stomach acid (FAMOTIDINE), sickness (ONDANSETRON), pain (PARACETAMOL), and inflammation (DEXAMETHASONE, TOCILIZUMAB).

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Synthorx Inc.

Enrolment target

Start

07 Feb 2024

Cancer

What is this study about?

This study is a clinical trial, which means it's a careful way of testing new treatments to see if they're safe and effective. It's called an 'open-label' study, which simply means both the researchers and the participants will know which treatment is being given.

The main medicine being tested is called THOR-707. Researchers want to understand how much of THOR-707 can be given safely without causing too many side effects, and what dose works best to treat advanced or spreading solid tumours (cancers that form solid lumps, like breast or lung cancer, rather than blood cancers).

This trial is in its early stages (Phase 1 and Phase 2). In Phase 1, the main focus is on safety and finding the right dose. In Phase 2, the researchers then look more closely at how well the treatment works against the cancer. They will be looking to see if THOR-707 can shrink tumours or stop them from growing, and also how it affects a person's overall health and quality of life. The study will test THOR-707 both on its own and in combination with other medicines, to see which approach is most promising.

Key takeaways

Tests a new medicine, THOR-707, for advanced solid cancers.
Aims to find the safest and most effective dose.
Closely monitors for side effects.
May involve other standard medicines to manage symptoms.
For adults aged 18 and over with advanced or spreading solid tumours.
You can stop participating at any time.

Who may be eligible?

This study is for adult patients who have been diagnosed with advanced or spreading solid tumours. You must be at least 18 years old to take part. There is no upper age limit, meaning older adults can also be considered.

The medical team will carefully review your health information and do some tests to make sure that taking part in this study is safe and appropriate for you. They will check your overall health and how well your body systems are working.

Specific details about who can or cannot join will be discussed thoroughly with you and your doctor. It's important that you meet all the study requirements to ensure your safety and the accuracy of the study results.

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 advanced or spreading solid tumour cancer?
Are you able to attend regular hospital or clinic visits?
Are you willing for your health to be closely monitored with tests and scans?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new medicine, THOR-707, either by itself or along with other treatments. You will have regular visits to the hospital or clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits will also track any side effects you might experience.

To help manage any potential side effects like allergies, stomach upset, or pain, you might also be given other commonly used medicines such as DIPHENHYDRAMINE (for allergies), FAMOTIDINE (for stomach acid), ONDANSETRON (for nausea/sickness), PARACETAMOL (for pain), and DEXAMETHASONE or TOCILIZUMAB (to help with inflammation). The total length of your participation in the study will depend on how you respond to the treatment and what the study doctors decide is best for you, but it will involve ongoing assessments as long as you are receiving the study medication.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, and this treatment could potentially help control your cancer. However, there's no guarantee the treatment will work for you, and it could have side effects, some of which might be serious or unexpected. The research team will monitor you very closely for any side effects and manage them as best as possible. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Spain

Common questions

What type of cancer is this study for?

This study is for adults with advanced or spreading 'solid tumours', which means cancers that form a solid lump, rather than blood cancers.

What is THOR-707?

THOR-707 is a new experimental medicine being tested in this study. It's not yet approved for general use.

Will I know if I'm getting the new medicine?

Yes, this is an 'open-label' study, meaning you and your doctors will both know that you are receiving THOR-707.

What are Phase 1 and Phase 2 studies?

Phase 1 studies primarily focus on finding the safest dose and understanding side effects. Phase 2 studies then look more closely at how well the treatment works against the cancer, while still monitoring safety.

Can I take other medicines during the study?

You might be given other medicines (like for allergies, sickness, or pain) to help with potential side effects from THOR-707. Your study doctor will discuss all medications with you.