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Safety and Efficacy of L19TNF Plus Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma

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NCT04443010 · readout ≤ 73 d

Sponsored by Philogen S.p.A. (industry) · PHIL.MI — their whole pipeline →.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
226estimated
Sites
1
Country
Switzerland

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-01-20actualWhen the study began enrolling
Primary completionOct 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionDec 2026estimatedThe whole study's end, after follow-up
First posted2020-06-23actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2023-10-10actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Glioblastoma

Interventions

  • Drug: Onfekafusp alfa — also filed as L19TNF
  • Drug: Temozolomide — also filed as TMZ

Primary outcomes

what the primary-completion date above is the date OF
For Phase 1: DLT
measured For Cohort 1 and Cohort 2 from Day 1 to Day 28 of the maintenance cycle; for Cohort 3, 4 and 5 from Day 1 to Day 42 of the chemoradiotherapy.
For Phase 2: Overall Survival
measured From beginning of treatment to 52 weeks

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