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

A phase Ib/II single-arm, multicenter study of sacituzumab-govitecan, a TROP-2 targeting antibody linked with SN38, for patients with metastatic esophagogastric adenocarcinoma

This study is looking at an investigational new medicine called Sacituzumab Govitecan. It targets a specific protein, TROP-2, found on some cancer cells in people with advanced oesophageal or stomach cancer that has spread to other parts of the body (metastatic esophagogastric adenocarcinoma). The main goal of the study is to find out how effective this new medicine is at shrinking tumours, known as the 'overall response rate'. This involves seeing if participants experience a complete disappearance or a significant reduction in their cancer. This study combines initial safety tests (Phase I) with early effectiveness tests (Phase II) to gather important information about this potential treatment for people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Institut fuer Klinische Krebsforschung IKF GmbH

Enrolment target

Start

18 Oct 2023

metastatic esophagogastric adenocarcinoma (Stage IV)

What is this study about?

This study is a clinical trial exploring a new medicine called Sacituzumab Govitecan for patients with a type of stomach or food pipe cancer that has spread. This advanced stage is sometimes called metastatic esophagogastric adenocarcinoma. The medicine works by specifically targeting a protein called TROP-2, which is often found on these cancer cells. By attaching to this protein, the medicine aims to deliver a cancer-fighting drug directly to the tumour.

The main purpose of this study is to see how well Sacituzumab Govitecan can make tumours shrink or disappear. This is measured by something called the 'overall response rate'. Researchers want to know if patients have a 'complete response' (where the cancer seems to fully go away) or a 'partial response' (where the cancer shrinks significantly). This helps them understand if the medicine is an effective treatment option.

This is an 'integrated' Phase I and Phase II study. This means it combines early safety testing (Phase I) with initial effectiveness testing (Phase II). It's a single-arm study, which means everyone in the study will receive the new medicine. It's also 'multicenter', meaning it's taking place in several different hospitals or clinics, which helps gather more information faster. The results from this study will help doctors learn more about this potential new medicine and how it might help patients with advanced oesophageal or stomach cancer.

Key takeaways

The study tests a new medicine, Sacituzumab Govitecan, for advanced stomach/oesophageal cancer.
It aims to see if the medicine shrinks cancer (overall response rate).
It's for adults with cancer that has spread (metastatic).
Participation involves regular treatments and health checks.
Potential benefits include access to a new treatment, but risks and side effects are possible.
You can stop participating at any time.

Who may be eligible?

To join this study, you would generally need to be an adult, at least 18 years old. Both men and women can take part.

You would need to have been diagnosed with advanced oesophageal or stomach cancer that has spread to other parts of your body. The study team will check your medical history and perform some tests to make sure that the study drug is suitable for you and that you meet all the other specific requirements. There will be other detailed criteria, such as your general health and how your organs are working, that the study team will review.

It's important to discuss your full medical history with the study doctor as certain prior treatments or health conditions might mean this study isn't right for you. They will explain exactly what is needed.

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?
Have you been diagnosed with advanced stomach or oesophageal cancer that has spread?
Are you able to travel to study appointments?
Are you generally feeling well enough to participate in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, Sacituzumab Govitecan. This medicine is given through a drip (intravenously) over a period of time, and you will need to attend hospital visits for these treatments. The frequency and duration of these visits will be clearly explained by the study team.

During your time in the study, you will have regular medical check-ups, blood tests, and scans (like CT or MRI scans) to monitor your health and see how the medicine is affecting your cancer. These assessments are important to track the treatment's effectiveness and to check for any side effects. After your treatment period, there will be a follow-up phase where the study team will continue to monitor your health for a certain amount of time. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but it will be thoroughly explained to you before you agree to take part.

Potential risks and benefits

Taking part in a clinical trial offers the chance to receive a new, investigative treatment that might help your condition, potentially before it's widely available. While the specific benefits cannot be guaranteed, the study aims to see if this medicine can shrink your cancer. However, as with all medicines, especially new ones, there are potential side effects and risks. These will be fully explained to you by the study team, and your health will be carefully monitored throughout. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Austria

Common questions

What kind of cancer is this study for?

This study is for people with advanced oesophageal (food pipe) or stomach cancer that has spread to other parts of the body.

What is Sacituzumab Govitecan?

It's a new investigational medicine being tested in this study. It's designed to target specific proteins on cancer cells and deliver a medicine to them.

What does 'overall response rate' mean?

It's how researchers measure if the cancer shrinks or disappears in response to the treatment. It includes complete responses (cancer gone) and partial responses (cancer shrunk a lot).

Can I still get my usual cancer treatment if I join?

That depends on the study's rules. You will receive the study medicine, and standard treatments might be paused or adjusted. This will be fully discussed with you by the study doctor.

Will I have to pay to be in the study?

No, clinic visits and study treatments are normally paid for by the study sponsor. You may be reimbursed for travel costs, but you should ask the study team about this.