RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

This research is investigating new ways to treat advanced stomach (gastric), gullet (oesophageal), or gastroesophageal junction cancer that can't be removed by surgery or has spread. Researchers are testing a new drug called ABBV-400 alongside standard chemotherapy (Fluorouracil and Leucovorin) and another experimental drug, Budigalimab. The main goals are to check for side effects, find the best dose of ABBV-400, and see how much the treatment can shrink the cancer or stop it from growing. About 180 adults will join this worldwide study, which will last for around six years. Participants will have regular hospital visits for assessments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

180

Start

13 Dec 2024

Estimated completion

01 Oct 2030

Locally Advanced Unresectable or Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma

What is this study about?

This clinical trial is designed to investigate new treatment options for people with advanced stomach cancer, cancer that starts where the gullet joins the stomach (gastroesophageal junction), or gullet cancer itself. This specifically applies to cancers that have spread to other parts of the body (metastatic) or are too advanced to be removed by surgery.

The study combines a new, experimental drug called ABBV-400 with two standard chemotherapy drugs, Fluorouracil and Leucovorin. It also includes another experimental drug, Budigalimab. The researchers want to find the safest and most effective amount (dose) of ABBV-400 to give. They also want to understand any side effects people might have and how well this combination of medicines works to shrink the cancer or slow its growth.

Initially, a small group of participants will receive increasing doses of ABBV-400 to find a safe and promising dose. After this, other participants will be divided into different groups. Some will receive Budigalimab with a common chemotherapy treatment called FOLFOX (Fluorouracil, Leucovorin, and Oxaliplatin). Other groups will receive the new combination with ABBV-400 at two different optimal doses, allowing researchers to gather more information about its effectiveness. This study aims to help find better treatments for these types of cancer.

Key takeaways

New experimental drugs (ABBV-400 and Budigalimab) are being tested alongside standard chemotherapy.
The aim is to find effective doses, assess side effects, and see how well the treatment works for advanced stomach/gullet cancers.
This is a worldwide study involving around 180 adults.
Participation includes regular clinic visits for treatments, tests, and monitoring.
The study has different phases: finding the right dose, then comparing different treatment combinations.
It's a long-term study, expected to last about six years.

Who may be eligible?

To be considered for this study, you must be an adult with a confirmed diagnosis of advanced stomach, gullet, or gastroesophageal junction cancer that cannot be surgically removed or has spread. Your cancer should also not have received prior treatment in this advanced stage.

Doctors will need to be able to measure your cancer to track how it responds to treatment. Your general health and ability to carry out daily activities will be assessed (known as an 'ECOG performance status' of 0 or 1, meaning you're quite active).

Additionally, your cancer cells will be checked for specific features: they must be 'HER2 negative' and doctors need to know your 'PD-L1 status' from a recent test or have a sample of your cancer tissue available for testing. You cannot have any significant ongoing or past major lung problems, among other conditions, to join this study.

Quick self-check

Do you have advanced stomach, gullet (oesophageal), or gastroesophageal junction cancer that has spread or can't be removed by surgery?
Have you not received prior treatment for your advanced cancer?
Are you generally well and active enough for daily tasks?
Has your cancer been tested and confirmed as 'HER2 negative'?
Is a sample of your tumour available for testing of 'PD-L1 status'?
Do you have any significant ongoing lung health issues?

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

What does participation involve?

If you decide to take part in this study, you will have regular visits to a hospital or clinic. These visits will involve various medical checks, blood tests, and sometimes filling out questionnaires about how you are feeling and any side effects you might be experiencing. The study treatments will be given intravenously, meaning into a vein.

The study is expected to last for about six years. Initially, you might receive different doses of the experimental drug until a suitable dose is found. After this, you would be assigned to one of several treatment groups. Throughout the study, medical staff will frequently monitor your health and the effect of the treatment on your cancer.

Potential risks and benefits

Taking part in a clinical trial means you might receive a new treatment that could potentially be more effective than standard care, but it's not guaranteed. There's a chance the new drugs might not work for you or could cause side effects, some of which might be serious or currently unknown, as these are new medicines. The regular hospital visits and tests might also be more demanding than your usual care. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (49)

City of Hope National Medical Center /ID# 268690
Duarte, United States· Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 272630
Irvine, United States· Recruiting
UCLA - Santa Monica /ID# 270024
Santa Monica, United States· Recruiting
AdventHealth Orlando /ID# 268561
Orlando, United States· Recruiting
City Of Hope - Atlanta. /ID# 280646
Newnan, United States· Recruiting
Hattiesburg Clinic /ID# 268572
Hattiesburg, United States· Recruiting
Duke University Medical Center /ID# 268186
Durham, United States· Recruiting
Millennium Research & Clinical Development /ID# 268540
Houston, United States· Recruiting
Algemeen Ziekenhuis klina /ID# 268754
Brasschaat, Belgium· Recruiting
Universitair Ziekenhuis Leuven /ID# 269957
Leuven, Belgium· Recruiting
CHU de Liege /ID# 270223
Liège, Belgium· Recruiting
Princess Margaret Cancer Centre /ID# 268277
Toronto, Canada· Recruiting

+37 more sites — see the official record for the full list.

Common questions

What type of cancer is this study for?

This study is for advanced stomach cancer, gullet cancer, or cancer where the gullet joins the stomach, especially if it cannot be removed by surgery or has spread.

What are 'investigational drugs'?

Investigational drugs are new medicines that are still being tested to see if they are safe and effective. They are not yet approved for general use.

How long will the study last?

The study itself is expected to run for about six years. Your individual participation duration will be discussed by your medical team.

Will I know which treatment I am receiving?

Initially, you'll receive part of the study drug as doctors figure out the best dose. After that, you'll be randomly assigned to a treatment group, which may or may not be known to you or your doctor, depending on the study design details.

What does 'intravenous (IV)' mean?

Intravenous means the medicine is given directly into your bloodstream through a vein, usually in your arm, using a drip.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

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