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

Active:	Yes
Cancer Type:	Lung Cancer Pancreatic Cancer	NCT ID:	NCT02912949
Trial Phases:	Phase II	Protocol IDs:	MCLA-128-CL01 (primary) NCI-2019-06025 2014-003277-42
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Merus N.V.
NCI Full Details:	http://clinicaltrials.gov/show/NCT02912949

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)

Objectives

Study Design :

This open label (all participants know the identity of the study drug), multicenter (more
than one study site), first-in-human study consisting of 2 parts. Part 1 is a dose
escalation and Part 2 is a dose expansion cohort. Part 1 has been completed.

Part 2 new patient populations examined:

- Group F: Patients with NSCLC with documented NRG1 fusion

- Group G: Patients with pancreatic adenocarcinoma with documented NRG1 fusion

- Group H: Patients with any other solid tumor with documented NRG1 fusion

For these new patient populations, Part 2 will further characterize the safety and
tolerability of the selected dose level of zenocutuzumab (MCLA-128), as well as
assessment of CBR, defined as the proportion of patients with a CR, PR or durable SD (SD
for at least 24 weeks in duration). For the new patient populations, overall response
rate (ORR) and duration of response (DOR) will be described.

The study consists of 3 periods: Screening period (up to 28 days prior to the first dose
of study drug); Treatment period (treatment cycles of 28 days); and Follow Up period
(through 30 days after the last dose and quarterly checks for survival data for up to 2
years). Participants' safety will be monitored throughout the study.

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