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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hemoglobin ≥8 g/dL or ≥5 mmol/L
Able to provide a tumor biopsy sample (fresh strongly preferred or else archival)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up6-12 months
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Solid Tumors Harboring NRG1 Fusion
- Non-Small Cell Lung Cancer
- Pancreatic Cancer
- Neuroblastoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your hemoglobin level needs to be at least 8 g/dL or 5 mmol/L.
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You can provide a small piece of your tumor for testing, either a fresh sample or one that was saved from an earlier biopsy.
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You are expected to live for at least 12 more weeks.
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You have already tried the usual treatment for your type and stage of cancer, or the doctor believes you wouldn't benefit from it.
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You have a specific gene fusion called NRG1 in your advanced cancer that has been confirmed by a specific type of genetic test.
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You have recovered from any major surgery or complications to a level no worse than Grade 2 or your health before the study.
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Your kidney function is good, with a GFR of more than 30 mL/min.
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You have a specific measurable or evaluable disease according to certain guidelines.
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You are able to perform daily activities with little to no help.
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Your white blood cell count is at least 1.5 x 10^9/L without needing special medication for at least 7 days before screening.
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Your platelet count is at least 100 billion per liter without needing a transfusion in the last 7 days.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of response per RECIST v1.1 as per local Investigator's assessment.
Objective overall response rate (ORR) as per local investigator's assessment
Secondary outcome measures
Area under the concentration versus time curve from time zero to time t [AUC0-t]
Characterize the safety and tolerability of zenocutuzumab (MCLA-128)
Clinical Benefit Rate (CBR) of zenocutuzumab (MCLA-128) assessed locally and centrally
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Part 2 Solid tumour (basket) harboring NRG1 fusionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Group II: Part 2 Pancreatic adenocarcinoma harboring NRG1 fusionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Group III: Part 2 NSCLC cancer harboring NRG1 fusionExperimental Treatment1 Intervention
Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks.
Find a Location
Who is running the clinical trial?
Merus N.V.Lead Sponsor
7 Previous Clinical Trials
1,111 Total Patients Enrolled
Alison Schram, MDPrincipal InvestigatorMemorial Sloan Kettering Medical Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor thinks you will live for at least 12 more weeks.Your hemoglobin level needs to be at least 8 g/dL or 5 mmol/L.You can provide a small piece of your tumor for testing, either a fresh sample or one that was saved from an earlier biopsy.You have brain metastases that are causing symptoms or are not stable.You have cancer that has spread to the fluid around your brain and spinal cord.You have a history of heart problems like congestive heart failure, unstable angina, or heart attack.You are expected to live for at least 12 more weeks.You have already tried the usual treatment for your type and stage of cancer, or the doctor believes you wouldn't benefit from it.You have a specific gene fusion called NRG1 in your advanced cancer that has been confirmed by a specific type of genetic test.You have recovered from any major surgery or complications to a level no worse than Grade 2 or your health before the study.Your kidney function is good, with a GFR of more than 30 mL/min.You are allergic to any of the ingredients in MCLA-128.You have HIV, active Hepatitis B, or Hepatitis C without receiving treatment. If you have been treated for Hepatitis C and have undetectable viral levels, you can participate.You had a cancer, other than certain skin or cervical cancers, that was treated with the goal of curing it more than 2 years ago.You have a specific measurable or evaluable disease according to certain guidelines.You are able to perform daily activities with little to no help.Your white blood cell count is at least 1.5 x 10^9/L without needing special medication for at least 7 days before screening.Your platelet count is at least 100 billion per liter without needing a transfusion in the last 7 days.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.You are expected to live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
The University of Texas MD Anderson Cancer Center
Virginia Mason Hospital & Seattle Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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