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

Running, not enrolling · Phase 2

Conditions studied: Solid Tumours Harboring NRG1 Fusion, NSCLC Harboring NRG1 Fusion, Pancreatic Cancer Harboring NRG1 Fusion, NRG1 Fusion

In brief

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)

Key facts

Study ID: NCT02912949
Run by: Partner Therapeutics, Inc.
People needed: 250
Starts: 2015-01-01
Expected to finish: 2026-12-31
Last updated by the study team: 2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
more than 14 days or more than 5 half-lives prior to study entry, whichever is shorter.
more than 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 screening;
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 more than 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.

You may not qualify if…

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 below 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 ability to sign informed consent, cooperate or participate in the study, or interfere with the interpretation of the results.

Where it is running

The Oncology Institute of Hope and Innovation — Cerritos, California, United States
University of California Irvine — Irvine, California, United States
Stanford University — Palo Alto, California, United States
Sharp Memorial Hospital — San Diego, California, United States
Georgetown University — Washington D.C., District of Columbia, United States
Memorial Cancer Institute — Hollywood, Florida, United States
Cancer Specialists of North Florida — Jacksonville, Florida, United States
Mayo Clinic — Jacksonville, Florida, United States
Emory Winship Cancer Institute — Atlanta, Georgia, United States
Northwest Oncology & Hematology — Rolling Meadows, Illinois, United States
Dana Farber Cancer Center — Boston, Massachusetts, United States
Karmanos Cancer Center — Detroit, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
Billings Clinic Cancer Center — Billings, Montana, United States
St. James Healthcare — Butte, Montana, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Averra Medical Group — Sioux Falls, South Dakota, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Huntsman Cancer Institute — Salt Lake City, Utah, United States
Utah Cancer Specialists — Salt Lake City, Utah, United States
Hematology-Oncology Specialist of Fredericksburg — Fredericksburg, Virginia, United States
Virginia Mason Hospital & Seattle Medical Center — Seattle, Washington, United States
Hematology Oncology Associates — Spokane, Washington, United States
Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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