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


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Trial ID: NCT02912949


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)

Official Title

A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors (eNRGy)

Stanford Investigator(s)

James Ford
James Ford

Professor of Medicine (Oncology) and of Genetics and, by courtesy, of Pediatrics


Inclusion Criteria:

   - At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a
   limited number of patients (up to 15) in Group H;

   - Performance status of ECOG 0 - 2;

   - Estimated life expectancy of at least 12 weeks;

   - Toxicities incurred as a result of previous anti-cancer therapy resolved to ≤Grade 1;

   - Treatment with anti-cancer medication or investigational drugs within the following
   intervals before the first dose of MCLA-128:

      1. >14 days or >5 half-lives prior to study entry, whichever is shorter.

      2. >14 days for radiotherapy.

   - Recovery from major surgery or other complication to ≤ Grade 2 or baseline ;

   - Absolute neutrophil count ≥1.5 x 109/L without colony stimulating factor support for
   at least 7 days prior to screening;

   - Platelets ≥75 x 109/L without transfusion support for at least 7 days prior to

   - Hemoglobin ≥8 g/dL or ≥5 mmol/L;

   - 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;

   - Estimated glomerular filtration rate (GFR) of >30 mL/min

   - Able to provide a tumor biopsy sample (fresh strongly preferred or else archival);

   - Not pregnant or nursing

   - Fertile patients must use effective contraception during and for 6 month after
   completion of study therapy;

   - 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;

   - 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:

   - Pregnant or lactating;

   - Presence of an active uncontrolled infection or an unexplained fever;

   - Known hypersensitivity to any of the components of MCLA-128;

   - Known HIV, active Hepatitis B without receiving antiviral treatment, or Hepatitis C;
   patients treated for Hepatitis C and have undetectable viral loads are eligible

   - Known symptomatic or unstable brain metastases;

   - Patients with leptomeningeal metastases;

   - Presence of LVEF <50% on the screening echocardiogram; or history or presence of any
   significant cardiovascular disease, including unstable angina or myocardial infarction
   within 12 months prior to screening, congestive heart failure (NYHA Class III or IV),
   or ventricular arrhythmia requiring medication;

   - 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;

   - 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.


drug: zenocutuzumab (MCLA-128)


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Aja Macias

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