For Healthcare Professionals

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

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About the study

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 10) in Group H;
  2. Performance status of ECOG 0
  3. 2;
  4. Estimated life expectancy of at least 12 weeks;
  5. Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1;
  6. Treatment with anti-cancer medication or investigational drugs within the following intervals before the first dose of MCLA-128:
  7. >14 days or >5 half-lives prior to study entry, whichever is shorter.
  8. >14 days for radiotherapy.
  9. Recovery from major surgery or other complication to ≤ Grade 2 or baseline ;
  10. Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for at least 7 days prior to screening;
  11. Platelets ≥100 x 109/L without transfusion support for at least 7 days prior to screening;
  12. Hemoglobin ≥8 g/dL or ≥5 mmol/L;
  13. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN; in cases of metastatic liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed; in cases of antecedents of Gilbert's syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed;
  14. Estimated glomerular filtration rate (GFR) of >30 mL/min
  15. Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);
  16. Not pregnant or nursing
  17. Fertile patients must use effective contraception during and for 6 month after completion of study therapy;
  18. Patients must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy or no satisfactory alternative treatment options are available;
  19. Locally-advanced unresectable or metastatic solid tumor malignancy with documented NRG1 gene fusion, identified through molecular assays such as next generation sequencing-based assays [DNA or RNA], as routinely performed at CLIA or other similarly-certified laboratories.

EXCLUSION CRITERIA

  1. Pregnant or lactating;
  2. Presence of an active uncontrolled infection or an unexplained fever;
  3. Known hypersensitivity to any of the components of MCLA-128;
  4. Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C; patients treated for Hepatitis C and have undetectable viral loads are eligible
  5. Known symptomatic or unstable brain metastases;
  6. Patients with leptomeningeal metastases
  7. Presence of congestive heart failure or Left Ventricular Ejection Fraction<50% or history of significant cardiac disease, unstable angina, myocardial infarction or ventricular arrhythmia requiring medication.
  8. Previous or concurrent malignancy (excluding non-basal cell carcinoma of skin or carcinoma in situ of the uterine cervix) unless the tumor was treated with curative intent more than 2 years prior to study entry;
  9. Presence of any other medical or psychological condition deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-833-NRG-1234Email iconEmail Study Center

Study’s details


Contition

Breast Cancer,Colorectal Cancer,Endometrial Cancer,Gastric Cancer,Malignant Solid Tumour,NRG1 Fusion,NSCLC Harboring NRG1 Fusion,Non Small Cell Lung Cancer,Ovarian Cancer,Pancreatic Cancer Harboring NRG1 Fusion,Solid Tumours Harboring NRG1 Fusion

Age (in years)

18 - 200

Phase

Phase 2

Participants needed

250

Est. Completion Date

Dec 2024

Treatment type

Interventional


Sponsor

Merus N.V.

ClinicalTrials.gov identifier

NCT02912949

Study number

MCLA-128-CL01

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