Active not recruitingPHASE1INTERVENTIONAL

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

This research study is testing a new medication called ABBV-400, which is an experimental drug for people with advanced solid cancers, including certain lung (NSCLC), stomach, and bowel cancers. We want to see how safe ABBV-400 is and if it helps control the cancer. The study will look at ABBV-400 on its own and also in combination with another approved cancer drug called bevacizumab. It's for adults whose cancer has gotten worse despite standard treatments. We'll be carefully checking for any side effects and how the cancer responds to the treatment.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AbbVie

Enrolment target

520

Start

13 Oct 2021

Estimated completion

01 Nov 2027

Non-Small Cell Lung Cancer Advanced Solid Tumors Gastroesophageal Adenocarcinoma Colorectal Cancer

What is this study about?

When cancer cells grow and spread in the body without control, doctors call this an 'advanced solid tumour'. This study is investigating a new treatment called ABBV-400 for adults who have advanced solid tumours, particularly focusing on certain types of lung cancer (non-small cell lung cancer), stomach and food pipe cancer (gastroesophageal adenocarcinoma), and bowel cancer (colorectal cancer).

The main goal of this research is to see how safe ABBV-400 is and to find out if it can slow down or reduce the size of these tumours. Because ABBV-400 is still an experimental drug, we need to carefully test different doses. The study is split into stages: first, a small group of participants will try increasing doses of ABBV-400 on its own to find the best dose. Then, a larger group will receive this best dose, sometimes on its own and sometimes combined with another standard cancer drug called bevacizumab. There might also be a comparison group receiving a different standard treatment.

Around 500 adult patients will take part in this study across many hospitals and clinics worldwide. By closely monitoring how patients respond and any side effects they experience, doctors hope to learn if ABBV-400 could be a helpful new option for people with these specific advanced cancers.

Key takeaways

This study tests a new drug, ABBV-400, for advanced lung, stomach, and bowel cancers.
It aims to find out if ABBV-400 is safe and if it helps shrink tumours.
You might receive ABBV-400 alone or with another cancer drug called bevacizumab.
Participation involves regular hospital visits for medication and health checks.
The treatment is experimental, so potential benefits and risks will be discussed.
You can withdraw from the study at any point.

Who may be eligible?

This study is looking for adult patients (18 years and older) who have been diagnosed with an advanced solid tumour. For the first part of the study, this could include types like lung, head and neck, stomach, bowel, and kidney cancer, where standard treatments haven't worked or aren't suitable, and surgery isn't an option.

For later parts of the study, specific types of lung cancer (non-small cell lung cancer) are needed. This includes those whose cancer has continued to grow after certain previous treatments, such as chemotherapy or targeted therapies. There are also specific requirements for people with advanced stomach or food pipe cancer and bowel cancer, usually meaning they have already tried one or two types of chemotherapy.

Generally, you would be considered if your current cancer treatments are no longer working or aren't suitable for you. A doctor will need to check your medical history and test results carefully to make sure you fit all the requirements for this study.

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 an advanced solid tumour (like specific lung, stomach, or bowel cancer)?
Have your previous cancer treatments not worked or are they no longer suitable?
Is your cancer measurable by current medical scans and tests?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to an approved hospital or clinic. These visits will involve various medical checks, including blood tests and questionnaires, to see how you are feeling and if the treatment is working. The study medicine, ABBV-400, will be given directly into your vein (intravenously) through a drip.

Some parts of the study combine ABBV-400 with other medicines like bevacizumab (also given intravenously) or trifluridine/tipiracil (taken as tablets). You will be closely monitored for any side effects throughout the study. Because this is an investigational treatment, you might have more appointments and tests than you would with standard care. Medical staff will track your progress, and you'll have specific follow-up appointments. The total duration of your participation will depend on how you respond to the treatment, but you can always discuss this in detail with the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, which could help your cancer when standard treatments haven't. However, this is an experimental drug, so we don't fully know all its effects. There's a chance ABBV-400 might not help your cancer, or it could cause side effects, some of which could be serious. All potential side effects will be explained to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (82)

University of California, Los Angeles /ID# 243841
Verified postcode
Los Angeles, United States
University Of Colorado Denver /ID# 231574
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Aurora, United States
Yale School of Medicine /ID# 248418
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New Haven, United States
University of Illinois Hospital and Health Sciences System /ID# 251386
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Chicago, United States
Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338
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Fort Wayne, United States
Indiana University Melvin and Bren Simon Cancer Center /ID# 245133
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Indianapolis, United States
Community Health Network, Inc. /ID# 245331
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Indianapolis, United States
Comprehensive Cancer Centers of Nevada /ID# 242930
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Henderson, United States
START Midwest /ID# 231551
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Grand Rapids, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668
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New York, United States
Duke Cancer Institute /ID# 247236
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Durham, United States
Carolina BioOncology Institute /ID# 231541
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Huntersville, United States

Common questions

What is ABBV-400?

ABBV-400 is a new medicine being tested to treat advanced cancers. It's a 'called an investigational drug' because it's not yet approved for general use.

What types of cancer is this study looking at?

This study focuses on advanced solid tumours, particularly certain types of lung (non-small cell), stomach and food pipe, and bowel cancer.

Will I get ABBV-400 or another medicine?

You might receive ABBV-400 on its own, or in combination with another approved cancer drug called bevacizumab, or possibly another standard treatment called trifluridine/tipiracil, depending on which part of the study you join.

How long will I be in the study?

The length of time you'll be in the study depends on how you respond to the treatment and what the doctors decide is best for you. It varies for each person.

Can I leave the study if I want to?

Yes, you can leave the study at any time, for any reason, without it affecting the standard medical care you receive.