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NotableLead sponsor: Merus B.V. to Partner Therapeutics, Inc.v22
MinorSite details revised at 1 of 64 sitesv21
MinorRe-verified, no change to tracked fieldsv20
MinorTrial status: Recruiting to Active, Not Recruiting
Study sites: 65 to 64
v19
MinorSite details revised at 7 of 65 sitesv18
Show 16 earlier versionsHide 16 earlier versions
MinorSite details revised at 3 of 65 sitesv17
MinorSite details revised at 2 of 65 sitesv16
MinorEligibility criteria expanded, about 9 words
Secondary endpoints revised (17)
Study description shortened, about 12 words
v15
NotablePrimary completion date: Dec 31, 2022 to Dec 31, 2026v14Show 5 more changesShow less
Study sites: 59 to 65
Study completion date: Dec 31, 2024 to Dec 31, 2026
Eligibility criteria expanded, about 17 words
Secondary endpoints: details revised at 1 of 17 entries
Study description revised
MinorStudy sites: 50 to 59v13
NotablePhase: Phase 1/2 to Phase 2v12Show 8 more changesShow less
Primary completion date: Sep 2021 to Dec 31, 2022
Primary endpoints: 7 to 2
Study sites: 35 to 50
Study completion date: Sep 2022 to Dec 31, 2024
Eligibility criteria expanded, about 28 words
Secondary endpoints: 13 to 17
Study description shortened, about 38 words
Study title expanded, about 1 word
MinorStudy sites: 27 to 35v11
MinorStudy sites: 25 to 27v10
MinorStudy sites: 26 to 25v9
MinorStudy description revised
Site details revised at 2 of 26 sites
v8
MinorSite details revised at 7 of 26 sitesv7
NotablePrimary endpoints revised (7)v6Show 4 more changesShow less
Interventions: MCLA-128 (Drug) to zenocutuzumab (MCLA-128) (Drug)
Secondary endpoints revised (13)
Study description expanded, about 1 word
Study title expanded, about 1 word
MinorStudy sites: 24 to 26v5
MinorSite details revised at 1 of 24 sitesv4
NotableEnrollment target: 130 to 250v3Show 10 more changesShow less
Primary completion date: Dec 2018 to Sep 2021
Primary endpoints: 2 to 7
Study sites: 7 to 24
Study completion date: Dec 2018 to Sep 2022
Eligibility criteria shortened, about 268 words
Secondary endpoints: 15 to 13
Study description shortened, about 9 words
Collaborators shortened, about 12 words
Study arms: 6 to 3
Study title expanded, about 4 words
NotablePrimary and study completion dates: Dec 2017 to Dec 2018v2Show 7 more changesShow less
Enrollment target: 120 to 130
Study sites: 6 to 7
Eligibility criteria expanded, about 195 words
Secondary endpoints revised (15)
Study description shortened, about 191 words
Collaborators: 3 to 4
Study arms: 3 to 6
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)