Spots Global Cancer Trial Database for F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer
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Trial Identification
Brief Title: F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer
Official Title: 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
Study ID: NCT05468294
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Basel University Hospital, Basel, , Switzerland
Contact Details
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