NCT05468294

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

Phase I/IIb Study of the Tumor Targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With the Anti-PD1 Antibody Nivolumab in Patients With Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study will take place in two phases. In Phase I, the MTD and RD will be defined following a traditional 3+3 design and patients will be treated in cohorts of 3 to 6 patients with a fixed dose of Nivolumab (3 mg/kg) and escalating doses of F16IL2. Following successful completion of the dose-finding, the study will proceed to Phase IIb and 17 patients will be treated with Nivolumab (3 mg/kg) and F16IL2 at the RD determined in Phase I.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	F16IL2	F16IL2 infusion will be always administered in 180 minutes i.v. on day 1, 8, 15 and 22 of each 28-days cycle.
DRUG	Nivolumab, fixed dose	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.

Timeline

• Start date: 2017-03-09
• Primary completion: 2021-12-31
• Completion: 2022-07-01
• First posted: 2022-07-21
• Last updated: 2022-07-21

Locations

1 site across 1 country: Switzerland