F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer

Sponsor
Philogen S.p.A.
Study ID
NCT05468294
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • F16IL2 — DRUG
    F16IL2 infusion will be always administered in 180 minutes i.v. on day 1, 8, 15 and 22 of each 28-days cycle.
  • Nivolumab, fixed dose — DRUG
    Patients will receive 3 mg/kg of Nivolumab as a 60 minutes i.v. infusion on day 1 and day 15 of each 28-days cycle.

Study Details

Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab.

Key Dates

Start date
Mar 9, 2017
Status verified
Jul 2022
Primary completion
Dec 31, 2021
Completion
Jul 31, 2022

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Ph I: F16IL2 + Nivolumab
    Patients will receive a fixed dose of Nivolumab and the following increasing dose levels of F16IL2: 15, 30, 50 and 70 Mio IU. Once the RD is established, 17 patients will receive a fixed dose of Nivolumab and F16IL2 at the RD, established during the Phase I part of the study.

Primary Outcome Measure

Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage - phase I study [ Time Frame: From Day 1 to Day 28 of treatment cycle ]

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