RecruitingPHASE1, PHASE2INTERVENTIONAL

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

This research study, called NAPISTAR 1-01, is looking into a new treatment named TUB-040 for people with specific types of ovarian cancer and non-small cell lung cancer that have either come back or not responded to usual treatments. TUB-040 is a special drug designed to target cancer cells more directly. The main goals are to find out if TUB-040 is safe, how well the body processes it, and if it can help improve the condition. The study will start by giving increasing doses to find the highest safe dose, and then compare different doses to see which one works best. Participants will receive TUB-040 through a drip every three weeks until their cancer gets worse or side effects become too strong.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Tubulis GmbH

Enrolment target

250

Start

12 Jun 2024

Estimated completion

01 Dec 2027

Ovarian Cancer Non-small Cell Lung Cancer

What is this study about?

This study is a clinical trial, which means it's a carefully planned research study to test a new treatment for people with specific health conditions. Here, the treatment is called TUB-040. We're looking at adults who have been diagnosed with ovarian cancer or a type of lung cancer called non-small cell lung cancer, and for whom standard treatments haven't been as effective as hoped, or their cancer has come back. The main aim is to understand if TUB-040 is a safe treatment, how the body handles it, and if it can help to shrink or control the cancer.

TUB-040 is a clever type of drug. Think of it like a sniffer dog that's been trained to find specific cancer cells. It's called an "antibody-drug conjugate." This means it's made up of two parts: one part (the antibody) is designed to stick to a specific marker (called NaPi2b) that is often found on the surface of some cancer cells, and the other part is a powerful anti-cancer medicine that gets delivered directly to those marked cells. This approach aims to attack the cancer cells more directly while ideally causing less harm to healthy cells.

The study has two main stages. In the first stage, a small group of patients will receive gradually increasing doses of TUB-040. This helps the study doctors find the highest dose that can be given safely without causing too many serious side effects. Once a safe dose range is found, the second stage will compare a couple of different doses within that range to figure out which dose works best for patients, balancing its effectiveness with any side effects.

Key takeaways

This study is for adults with advanced ovarian cancer or non-small cell lung cancer.
It's testing a new drug called TUB-040 that aims to target cancer cells.
The study has two parts: finding the safest dose and then the most effective dose.
Treatment is given through a drip every 3 weeks.
You must have already tried standard treatments.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Importantly, your cancer should not be treatable with standard methods that aim to cure it. You should also have already tried the usual treatments, and joining this study should not mean you miss out on any standard treatment that could still help you.

Doctors will also need to be able to measure your cancer on scans to see if the treatment is working. Your general health and fitness, as measured by a scale called ECOG, should be good (0 or 1). You should also be expected to live for more than 12 weeks, as assessed by the doctor.

There are also some requirements about your body's organ functions (like your liver and kidneys) being healthy enough, and any side effects from previous treatments (like chemotherapy or surgery) should have mostly gone away. Women who could become pregnant and men with partners who could become pregnant will need to use effective birth control during and for some time after the study.

Quick self-check

Are you 18 years or older?
Has your doctor said your cancer cannot be cured by standard treatments?
Have you already tried the usual treatments for your cancer?
Can your cancer be measured on scans?
Is your general health reasonably good (ECOG score 0-1)?

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 receive the study drug, TUB-040, through a drip into your vein. This treatment will be given every three weeks. You will continue to receive the treatment for as long as it is helping you and your cancer is not getting worse, or until you experience side effects that make it necessary to stop.

Throughout the study, you will have regular visits to the hospital for check-ups, blood tests, and scans (like CT scans of your chest) to monitor your health and see how the treatment is affecting your cancer. You’ll also have lung function tests at the beginning. You will also be asked to provide samples of any tissue (from a previous biopsy) for research purposes. The total length of your participation will depend on how you respond to the treatment and whether you experience any side effects.

Potential risks and benefits

Taking part in early-stage clinical trials like this one means there's a chance the new treatment might help your cancer, especially if standard options haven't worked. However, new treatments can also have side effects, some of which might be serious or unexpected. The research team will carefully monitor you for any side effects and manage them as best they can. There's no guarantee the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (15)

The University of Alabama
Birmingham, United States· Recruiting
Mount Sinai
New York, United States· Recruiting
Christ Hospital
Cincinnati, United States· Recruiting
Ohio State University
Columbus, United States· Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, United States· Recruiting
Next Oncology Dallas
Irving, United States· Recruiting
Next Oncology Virginia
Fairfax, United States· Recruiting
UZ Leuven
Leuven, Belgium· Recruiting
Charité Universitätsmedizin Berlin
Berlin, Germany· Recruiting
University Hospital Cologne Department of Internal Medicine I
Cologne, Germany· Recruiting
Arensia Exploratory Medicine
Cluj-Napoca, Romania· Recruiting
Clínica universidad de Navarra
Madrid, Spain· Recruiting

+3 more sites — see the official record for the full list.

Common questions

What does 'non-small cell lung cancer' mean?

It's the most common type of lung cancer, and this study focuses on that specific kind.

What is an 'antibody-drug conjugate'?

It's a clever drug that combines a targeting part (like a homing missile) with a medicine, aiming to deliver the medicine directly to cancer cells.

What does 'exhausted the standard of care treatment' mean?

It means you've already tried the usual, established treatments for your cancer that doctors would normally recommend, and they haven't been as effective as hoped.

How will I know if the treatment is working?

The study team will use regular scans and other tests to see if your cancer is shrinking or being controlled.

Can I stop being part of the study at any time?

Yes, you are always free to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Tubulis Clinical Trial Inquiries

ct-inquiries@tubulis.com + 49 175 800 5594 Official trial record

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