Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and preliminary Anti-Tumor activity of RO7616789 in participants with Advanced Small Cell Lung Cancer and other Neuroendocrine Carcinomas

This research study is looking at a new medicine called RO7616789. It's designed for people who have advanced small cell lung cancer or other types of neuroendocrine carcinomas, which are rare cancers that start in hormone-producing cells. In this very early stage of testing (Phase I), doctors want to learn several important things. They will check if the medicine is safe for people to take and what side effects it might cause. They also want to understand how the body uses and processes the medicine, and how it might affect the cancer. The main goal is to see if this new treatment can help slow down or stop the growth of these cancers.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

30 Nov 2023

Small Cell Lung Cancer and Neuroendocrine Carcinoma

What is this study about?

This research study is about a new medicine, called RO7616789, for certain types of cancer. Specifically, it's for people who have advanced small cell lung cancer or a group of rare cancers known as neuroendocrine carcinomas. These are cancers that start in special cells throughout the body that make hormones.

The main purpose of this study is to find out if this new medicine is safe for people. Because it's a very early-stage study (called Phase I), it's the first time this specific medicine is being given to humans. Researchers will carefully watch for any side effects and see how the body handles the medicine. They also want to understand how the medicine works inside the body, including how it might affect cancer cells.

The information gathered from this study will help doctors decide if RO7616789 should be studied further in larger groups of people. If it looks promising for safety and shows some signs of fighting cancer, it could potentially become a new treatment option in the future for people with these specific cancers.

Key takeaways

This study is testing a new cancer medicine called RO7616789.
It's for people with advanced small cell lung cancer or other neuroendocrine cancers.
It's an early-stage (Phase I) study focused on safety and understanding the medicine.
Participation involves regular clinic visits for tests and monitoring.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To join this study, people must be at least 18 years old. There is no upper age limit, meaning older adults can also take part if they meet other requirements. Both men and women are welcome to join.

Beyond age and sex, specific medical conditions and overall health will be carefully checked by the study doctors. For example, people must have either advanced small cell lung cancer or another type of neuroendocrine carcinoma. The doctors will review your medical history and perform tests to make sure the study is a good fit for you and that taking part would be safe.

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.

Am I at least 18 years old?
Do I have advanced small cell lung cancer or a neuroendocrine carcinoma?
Am I generally well enough to take part in a study?
Am I able to attend regular appointments for tests and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, RO7616789. You will need to attend regular appointments at the study clinic or hospital. These visits will involve various checks, such as physical exams, blood tests, and scans, to monitor your health, see how the medicine is affecting your body, and check for any changes in your cancer. The exact number of visits and tests will be explained to you by the study team.

You will continue to receive the medicine and have these check-ups for as long as the study doctors think it's safe and potentially helpful for you, or until your cancer worsens. You will also have follow-up appointments even after you stop taking the medicine, to make sure you are doing well. The total time you spend in the study will depend on your individual medical situation and the study plan, but it could last months or possibly longer.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main potential benefit of this study is that the new medicine, RO7616789, might help control your cancer, even though it's not guaranteed, especially since this is an early-stage trial. You would also be contributing to medical research that could help others in the future. Potential risks include side effects from the new medicine, which can be mild or more serious, and some study procedures, like blood tests, might cause discomfort. The study team will explain all known or expected risks to you. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Denmark
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Unverified
Poland
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Unverified
Spain
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Unverified
Germany
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Unverified
France

Common questions

What is 'advanced' cancer?

Advanced cancer means the cancer has spread from where it started to other parts of your body.

What are neuroendocrine carcinomas?

These are a group of unusual cancers that begin in cells that produce hormones throughout the body.

What does Phase I mean?

Phase I is the very first step of testing a new medicine in people. It mainly checks for safety and proper dosage.

Will I definitely get the new medicine?

Yes, in this study, all participants will receive the new medicine being tested.

Will I have to pay to be in the study?

No, you will not have to pay for the study medicine or procedures. Travel costs might be covered; ask the study team.