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Monoclonal Antibodies

Zenocutuzumab for Solid Tumors

Mayo Clinic, Jacksonville, FL
Targeting 4 different conditionszenocutuzumab (MCLA-128)Phase 2RecruitingLed by Alison Schram, MDResearch Sponsored by Merus N.V.

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 below
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 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 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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

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 more

Awards & 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

Zenocutuzumab (MCLA-128) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02912949 — Phase 2
Solid Tumors Research Study Groups: Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion, Part 2 NSCLC cancer harboring NRG1 fusion, Part 2 Solid tumour (basket) harboring NRG1 fusion
Solid Tumors Clinical Trial 2023: Zenocutuzumab (MCLA-128) Highlights & Side Effects. Trial Name: NCT02912949 — Phase 2
Zenocutuzumab (MCLA-128) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02912949 — Phase 2

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?
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
~25 spots leftby Nov 2024