RecruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

This research study, called a Phase 1/2 trial, is for adults with advanced solid cancers like bowel (colorectal) cancer, head and neck squamous cell cancer, non-small cell lung cancer, and stomach (gastric or gastroesophageal junction) cancer. We are testing a new medicine called TH9619. This is the very first time TH9619 is being used in people, so the main goals are to find out if it's safe, how much to give, and if it has any effect on the cancer. Participants will receive TH9619, and doctors will carefully watch how their bodies react to it. Everyone in the study will know they are receiving the experimental medicine.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

One-carbon Therapeutics AB

Enrolment target

Start

22 Aug 2025

Estimated completion

01 Dec 2026

Solid Tumor Colorectal Cancer (CRC)Squamous Cell Carcinoma of Head and Neck Non-Small Cell Lung Cancer (NSCLC)Gastrooesophageal Junction Cancer Gastric Cancer

What is this study about?

This study is an important step in developing new treatments for advanced cancers. When a new medicine like TH9619 is discovered, it first goes through extensive testing in laboratories. If those tests are promising, it then moves to human trials, starting with what are called 'Phase 1' studies.

This particular study is a 'Phase 1/2' trial. This means it has two main parts. The first part (Phase 1) is all about safety and finding the right dose. Because TH9619 has never been given to people before, doctors will start with a very small dose and gradually increase it in different groups of patients, watching very carefully for any side effects. The goal is to find a dose that is both safe and potentially effective. The second part (Phase 2) will then use that dose in a larger group of patients to get a better idea of how well it works against the cancer.

The study involves people with different types of advanced solid cancers, including bowel cancer (colorectal cancer), certain head and neck cancers (squamous cell carcinoma), non-small cell lung cancer, and stomach cancers (including those affecting the junction between the food pipe and stomach). All participants would have already received at least one other treatment for their cancer that hasn't worked as hoped. The information gathered from this study will help us understand if TH9619 could be a new and helpful treatment option in the future.

Key takeaways

This study is testing a brand-new medicine, TH9619, for advanced cancers.
It's a 'first in human' study, focused on safety and finding the best dose.
You would receive the new medicine and be closely monitored by doctors.
This research aims to find new treatment options for people with certain advanced solid tumours.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old, and have an advanced solid cancer that has been confirmed by a doctor. This includes specific types such as bowel cancer, a certain type of head and neck cancer, non-small cell lung cancer, or stomach cancer. You must have already tried at least one other medicine for your advanced cancer.

It's really important that you are willing to follow all the study instructions and attend appointments as needed. Before you can join, you'll need to read and sign a consent form, which explains everything about the study in detail.

However, there are some reasons why you might not be able to join. For example, if you have other serious medical conditions that your study doctor thinks would make it unsafe for you to take part, or might interfere with the study results, you would not be eligible.

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 doctor-confirmed advanced solid cancer (bowel, head & neck squamous cell, non-small cell lung, or stomach cancer)?
Have you already received at least one other treatment for your advanced cancer?
Are you able and willing to attend all study appointments and follow instructions?
Do you understand the study involves a new medicine being tested in humans for the first time?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the new medicine, TH9619, which is the treatment being tested. This is an 'open-label' study, meaning both you and your doctors will know you are receiving TH9619. You will have regular visits to the hospital or clinic for check-ups, where doctors will monitor your health, perform various tests, and watch for any side effects. These tests might include blood tests, scans, and physical examinations. The exact number of visits and tests will be explained to you before you join. The study will continue for a certain period, and you'll have follow-up appointments even after you stop taking the medicine to ensure your health is monitored. The full duration of your individual participation will depend on how you respond to the treatment and will be explained in detail.

Potential risks and benefits

Participating in any clinical trial involves both potential benefits and risks. A potential benefit of this study is that TH9619 might help to treat your cancer, and you would be among the first to receive this new medicine. You would also contribute valuable information that could help others in the future. However, there are also risks; TH9619 could cause side effects that are currently unknown or more severe than expected, as it is a new medicine being tested for the first time in people. These side effects could be mild or more serious. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
Vall D Hebron Institute Of Oncology
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Verified postcode
Madrid, Spain· Recruiting
Newcastle University
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is 'Phase 1/2'?

Phase 1 is the very first stage where doctors check if a new medicine is safe and find the right dose. Phase 2 then checks if the medicine shows any promise in treating the cancer.

What does 'first in human' mean?

This means TH9619 has never been given to people before; it's the first time it’s being tested in patients to see how it works and if it's safe.

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

Yes, this is an 'open-label' study, which means both you and your doctors will know that you are receiving TH9619.

What kind of cancers are included?

This study is for advanced bowel cancer, certain head and neck cancers, non-small cell lung cancer, and stomach cancer (including where the food pipe joins the stomach).

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your future medical care.

How to find out more

Victoria Moody

victoria.moody@one-carbon.com +46708555182 Official trial record

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