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

NCT02912949 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-04-29

No results posted yet for this study

Summary

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)

Conditions

  • Solid Tumours Harboring NRG1 Fusion
  • NSCLC Harboring NRG1 Fusion
  • Pancreatic Cancer Harboring NRG1 Fusion
  • NRG1 Fusion

Interventions

DRUG

zenocutuzumab (MCLA-128)

full length IgG1 bispecific antibody targeting HER2 and HER3

Sponsors & Collaborators

  • Partner Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Alison Schram, MD · Memorial Sloan Kettering Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02912949 on ClinicalTrials.gov