Studieoverzicht

Study name: A Phase 1, Open-Label, First-in-Human Study to Evaluate the Safety and Anti-tumour Activity of FS222, a CD137/PD-L1 Bispecific Antibody, in Subjects With Advanced Malignancies

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	Radboud UMC	Enrollment	Recruiting
Therapy line	Later line (≥2L)
PD-L1 expression	Negative: <1% , Low: 1 - 49% , High: ≥50%
Design	Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label)
Intervention	FS222 Q4W
Key inclusion criteria	Histologically or cytologically confirmed advanced/metastatic NSCLC previously treated with platinum-based chemotherapy (if appropriate) and a regimen containing a PD-1/PD-L1 inhibitor (alone or in combination with another agent). Subjects with tumours containing mutations for which an approved targeted therapy is available (i.e. EGFR, anaplastic lymphoma kinase (ALK), ROS1, TRK or RET) are not required to have received a prior PD-1/PD-L1 inhibitor but must have been treated with and progressed on or after at least one line of appropriate targeted treatment, if applicable. Subjects must be considered inappropriate to receive additional lines of standard therapy.
Key exclusion criteria	For participants who have received prior ICB, participants must not have received more than 1 line of prior treatment with ICB(s). Uncontrolled CNS metastases, primary CNS tumours with CNS metastases as only measurable disease. Exceptions as defined in protocol for PK/PD expansion cohorts will apply. Prior history of any Grade ≥3 irAE that has not improved to Grade ≤1, except for endocrine deficiencies that are managed by HRT; significant treatment-related cytokine release syndrome; systemic inflammatory response syndrome. Current use of immunosuppressive agents
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