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Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression

NCT05304663 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-04-08

No results posted yet for this study

Summary

Open label phase I study in subjects with glioblastoma at first progression to explore two different administration schedules of lomustine for the combination with L19TNF (ARM 1 and ARM 2).

Patients will be assigned in an alternating fashion to ARM 1 "Fractionating lomustine" or ARM 2 "Priming with L19TNF" as long as both treatment arms are open. Should one treatment arm be stopped as more or equal to two dose limiting toxicities occur in this treatment arm, then all remaining patients will be assigned to the treatment arm that is still open until also this treatment arm will be stopped.

Conditions

Interventions

DRUG

Onfekafusp alfa

Patients will be treated with 10 µg/kg L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26

DRUG

Lomustine

Arm 1: Patients will be treated in escalating cohorts of 6 patients with lomustine at different doses (60 mg/m2 and 75 mg/m2) on Day 1 and Day 22 (taken in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Arm 2: Patients will be treated in escalating cohorts of 6 patients with lomustine at different doses (90 mg/m2 and 110 mg/m2) on Day 5 (in the evening after infusion of L19TNF) of a 42-day cycle for up to a maximum of 6 cycles.

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-12-31
Completion
2024-12-31

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Diseases

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 NCT05304663 on ClinicalTrials.gov