Active not recruitingPHASE2INTERVENTIONAL

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

This research is testing a new medicine, zenocutuzumab, for people living with solid cancers that have a particular genetic alteration known as an NRG1 fusion. This includes certain lung cancers and pancreatic cancers. The main goals of the study are to understand how safe the drug is, how well people can tolerate it, and if it has a positive effect on their cancer. Doctors will be carefully monitoring participants throughout the study to track side effects and see how the cancer responds. This is a "Phase 2" study, meaning researchers are looking at the drug's effectiveness and safety in a larger group of people after initial safety tests.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Partner Therapeutics, Inc.

Enrolment target

250

Start

01 Jan 2015

Estimated completion

31 Dec 2026

Solid Tumours Harboring NRG1 Fusion NSCLC Harboring NRG1 Fusion Pancreatic Cancer Harboring NRG1 Fusion NRG1 Fusion

What is this study about?

You've been asked to consider taking part in a research study looking at a new medicine called zenocutuzumab (also known as MCLA-128). This study focuses on people who have certain types of solid cancers – like some lung cancers or pancreatic cancers – that have a specific change in their genes, called an NRG1 fusion. Imagine your body's cells have instruction manuals (genes); an NRG1 fusion is like a printing error in this manual that can sometimes cause cancer to grow.

The main purpose of this study is to see if zenocutuzumab is a safe and helpful treatment for these particular cancers. Researchers want to understand if the medicine can stop the cancer from growing, or even make it shrink. They'll also be carefully checking for any side effects and how your body reacts to the drug. This is an important step in developing new treatments for cancer.

This study is in "Phase 2," which means the drug has already been tested for safety in a small group of people. Now, researchers need to learn more about its effects in a larger group of patients with the specific type of cancer. All participants and their doctors will know they are receiving the study drug.

Key takeaways

This study tests a new drug, zenocutuzumab, for specific solid cancers with an NRG1 gene fusion.
It's a Phase 2 study focused on safety, side effects, and how well the drug works.
Participants will receive the study drug and be closely monitored.
The study involves a screening period, treatment, and follow-up for up to two years.
Participation could offer a new treatment option but also carries potential risks from side effects.

Who may be eligible?

To join this study, you generally need to be an adult (18 years or older) with a solid cancer that has an NRG1 fusion. You should have already tried standard treatments for your cancer, or your doctor thinks they wouldn't be right for you, or there aren't many other treatment options available.

Your general health needs to be good enough to take part. This means your doctor will check things like your blood counts, liver, and kidney function to make sure they are within a safe range. You also need to be able to move around reasonably well.

There are also some things that would mean you couldn't join. For example, if you're pregnant or breastfeeding. If you're a woman who could become pregnant, you'd need to use effective birth control during and for 6 months after the study. Also, if you've recently had other cancer treatments or major surgery, there are specific waiting periods before you could start 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 or older?
Do you have a solid cancer (e.g., lung, pancreas) with an NRG1 gene fusion?
Have you already tried standard treatments or is your doctor considering other options for you?
Are you generally well enough to participate, with good organ function?
If you're a woman who could become pregnant, are you willing to use effective birth control?
Have you recovered from any recent surgery or previous cancer treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several stages. First, there's a "screening period" for up to 28 days where you'll have tests to make sure you're suitable for the study. This might include blood tests, scans, and a tumour biopsy (taking a small sample of your cancer tissue), if you don't have a recent one.

If you qualify, you'll enter the "treatment period." You'll receive the study drug, zenocutuzumab. Treatment cycles last for 28 days, and you'll have regular visits to the clinic for treatments, check-ups, and to monitor for any side effects. These visits will also track how your cancer is responding to the treatment with more blood tests and scans.

After your treatment finishes, there's a "follow-up period." For 30 days after your last dose, there will be checks to make sure you're recovering well. Then, for up to two years, the research team will keep in touch about every three months to check on your overall health and survival. The total time you're involved could be several months for treatment, plus up to two years for follow-up.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. A potential benefit is that zenocutuzumab might help treat your cancer if other options haven't worked or aren't suitable. You would also be contributing to medical knowledge that could help future patients. However, there's no guarantee the drug will help your cancer. As with any medicine, zenocutuzumab could cause side effects, some of which might be serious. The research team will carefully monitor you for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (64)

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

Mayo Clinic
Verified postcode
Phoenix, United States
The Oncology Institute of Hope and Innovation
Verified postcode
Cerritos, United States
University of California Irvine
Verified postcode
Irvine, United States
Stanford University
Verified postcode
Palo Alto, United States
Sharp Memorial Hospital
Verified postcode
San Diego, United States
Georgetown University
Verified postcode
Washington D.C., United States
Memorial Cancer Institute
Verified postcode
Hollywood, United States
Cancer Specialists of North Florida
Verified postcode
Jacksonville, United States
Mayo Clinic
Verified postcode
Jacksonville, United States
Emory Winship Cancer Institute
Verified postcode
Atlanta, United States
Northwest Oncology & Hematology
Verified postcode
Rolling Meadows, United States
Dana Farber Cancer Center
Verified postcode
Boston, United States

Common questions

What is an NRG1 fusion?

An NRG1 fusion is a specific genetic change, or 'error' in a gene, found in some cancer cells. It can sometimes make the cancer grow and is the target of the new drug being tested.

What kind of cancer is this study for?

This study is for people with certain solid cancers, like some lung cancers or pancreatic cancers, that have the NRG1 gene fusion.

Is zenocutuzumab a new treatment?

Yes, zenocutuzumab is an investigational drug, meaning it's still being tested and is not yet approved for general use. This study aims to learn more about it.

How long will I be on the treatment?

Treatment cycles are 28 days long, and you will continue treatment for as long as your doctor and the study team believe it is helping you and you are tolerating it well. The total follow-up period could last up to two years.

Will I know if I'm getting the drug or a placebo?

Everyone in this study will receive the active study drug, zenocutuzumab. There is no placebo group.