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

A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Participants with Advanced or Metastatic Solid Tumors

This research is a early-stage study for a new investigational medicine called AZD7789. It's designed to help people with advanced forms of cancer, including stomach, gastro-esophageal junction (the area where the food pipe meets the stomach), and non-small cell lung cancer, as well as other solid tumors that have spread. The main goals are to check the medicine's safety, understand how it moves through and affects the body, and see if it can be effective in treating these cancers. Researchers will be looking for any side effects and how many patients show their tumors shrinking. This is an important step in developing new cancer treatments.

At a glance

Status

Ongoing, recruiting

Phase

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

Sponsor

AstraZeneca AB

Enrolment target

Start

31 May 2024

Advanced or metastatic gastric and gastro-esophageal junction (GEJ) adenocarcinoma Advanced or Metastatic Non-small Cell Lung Carcinoma Advanced or Metastatic Solid Tumors

What is this study about?

This research study is about a new medicine called AZD7789, which is designed to treat certain advanced cancers. These include cancers of the stomach, where the food pipe meets the stomach, and some types of lung cancer, as well as other solid tumors that have grown or spread in the body. The study is in its early stages, meaning it's one of the first times this medicine is being tested in people.

The main aims of this study are to make sure the medicine is safe to use and to understand how it works in the body. Researchers will carefully check for any side effects and see how the body handles the medicine. They also want to find out if AZD7789 can help control or shrink the cancer. This information is crucial for deciding if this medicine has the potential to become a new treatment option for people with these types of cancer.

By participating, volunteers are helping scientists learn more about this potential new treatment. The study progresses in steps, starting by carefully finding the right dose and then expanding to see how well it works for more people. Your involvement helps pave the way for future medical advancements.

Key takeaways

Tests a new medicine (AZD7789) for advanced cancers.
Aims to check safety and effectiveness.
For advanced stomach, lung, and other solid tumors.
Involves regular clinic visits and health checks.
Participation is voluntary and you can withdraw at any time.

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 looking for people who have advanced cancer, which means the cancer has spread or is difficult to treat with standard therapies.

This includes people with advanced stomach cancer, cancer at the junction of the food pipe and stomach, or a specific type of lung cancer called non-small cell lung cancer. It also includes people with other types of solid tumors that are considered advanced or have spread (metastatic).

There will be other detailed criteria, such as your general health, how well your organs are working, and any other medical conditions you might have. These will be checked by the study team to ensure the study is safe for you and that the results will be accurate.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of advanced stomach or gastro-esophageal junction cancer?
Do you have a diagnosis of advanced non-small cell lung cancer?
Do you have another type of advanced solid tumor that has spread?
Are you able to attend regular clinic appointments for treatment and check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to participate in this study, you will receive the new medicine, AZD7789. You will have regular visits to the clinic where the study team will monitor your health closely. These visits will involve various tests, such as blood tests, checking your heart's activity with an ECG, and taking measurements like your blood pressure and temperature. You will also have scans to see how your cancer is responding to the treatment. The total number of visits and the overall duration of your participation will depend on how you respond to the medicine and if you experience any side effects. After stopping the medicine, there will be follow-up appointments to continue monitoring your health.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new medicine that might help treat your cancer if standard treatments haven't worked well. However, like all medicines, AZD7789 might cause side effects, which can vary from mild to serious, and the medicine may not work for everyone. The research team will explain all known risks and monitor you closely for any unwanted effects. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

—
Spain
—
Netherlands
—
France

Common questions

What is AZD7789?

AZD7789 is a new investigational medicine being tested to treat advanced cancers.

Which cancers is this study for?

This study is for advanced stomach, advanced non-small cell lung cancer, and other advanced solid tumors.

What does 'advanced' cancer mean in this study?

'Advanced' cancer means the cancer has grown or spread, and current standard treatments may not be fully effective.

What is the main goal of this study?

The main goal is to check how safe the new medicine is and if it can help shrink tumors.

Can I stop participating if I want to?

Yes, you can choose to stop participating in the study at any time, for any reason.