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Zenocutuzumab for Solid Tumors
Study Summary
This trial is testing a new drug, zenocutuzumab, to see if it is safe and effective for treating patients with solid tumors that have an NRG1 fusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your liver enzyme levels and bilirubin levels should be within certain limits. If you have liver spread of cancer, slightly higher levels are allowed. If you have Gilbert's syndrome, higher bilirubin levels are allowed.I can provide a new or old sample of my tumor for testing.You are expected to live for at least 12 more weeks.I have HIV or untreated Hepatitis B, or I've been treated for Hepatitis C with no detectable virus now.I have brain metastases that are causing symptoms or are unstable.I have a fever or infection that isn't under control.I have heart issues like heart failure, low heart pump function, or serious heart rhythm problems.I had cancer before, but it was treated over 2 years ago.I have at least one tumor that can be measured or my disease can be evaluated in another specific way.I have recovered from major surgery with minimal side effects.My white blood cell count is healthy without needing medication for the past week.I am able to care for myself and perform daily activities.I will use birth control during and for 6 months after the study.I haven't taken any cancer drugs or experimental medications recently.My platelet count is healthy without needing a transfusion in the last week.My cancer is advanced, cannot be surgically removed, and has an NRG1 gene fusion.Your doctor thinks you will live for at least 12 more weeks.Your kidney function is good, with a GFR of more than 30 mL/min.My cancer has spread to the lining of my brain and spinal cord.You are allergic to any of the ingredients in MCLA-128.Side effects from my previous cancer treatments are mild.I have undergone or am considered unsuitable for standard cancer treatments.Your hemoglobin level needs to be at least 8 g/dL or 5 mmol/L.
- Group 1: Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion
- Group 2: Part 2 NSCLC cancer harboring NRG1 fusion
- Group 3: Part 2 Solid tumour (basket) harboring NRG1 fusion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are being recruited to take part in this experiment?
"To complete this study, 250 suitable candidates are required. Participation can occur at places like Mayo Clinic of Rochester and Karmanos Cancer Center in Detroit."
Is enrollment open for this clinical research endeavor?
"According to clinicaltrials.gov, the study is currently seeking participants since its original posting on January 1st 2015 and subsequent update on August 10th 2022."
Is this the inaugural attempt to conduct such an experiment?
"Since 2015, zenocutuzumab (MCLA-128) has been a major focus of scientific research. Merus N.V., who sponsored the inaugural trial in 2015 involving 250 patients, eventually saw their drug receive Phase 2 approval. Currently there are two ongoing trials for this medication distributed across 18 nations and 19 cities respectively."
How many clinical research centers are carrying out this trial?
"Currently, this medical trial is being conducted out of 13 sites across the continent. Patients can find a clinic in Detroit, Rochester and Toronto as well as 10 other cities to minimize travel strain should they choose to join."
What kind of safety measures have been taken to ensure people's wellbeing when using zenocutuzumab (MCLA-128)?
"Our team at Power assigned zenocutuzumab (MCLA-128) a score of 2, as the safety profile is supported by evidence from Phase 2 trials, yet there are no studies confirming its efficacy."
Are there any precedents of research with zenocutuzumab (MCLA-128)?
"Presently, two clinical trials of zenocutuzumab (MCLA-128) are ongoing. While neither is in Phase 3 yet, the research for this therapeutic agent is being conducted at 78 distinct sites across Clermont-Ferrand and California."
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