Clinical trial details

A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination With Anti-cancer Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor

Identifier

GCT1046-04

Sponsor

GENMAB S/A

Principal Investigator

ENRIQUETA FELIP FONT

Service

Oncology

Study details

Tumor type: LUNG-NSCLC
Stage: Advanced
Main Investigational Agent : Biespecific antibodies
Phase: II
Randomization: Randomized

Molecular details

Biomarker: PD-L1 pos
Biomarker criteria: Mandatory
Prescreening: Central
Additional study population requirements: Have histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease Have PD-L1 tumor expression score of TPS =1% assessed by a central laboratory during screening. Acasunlimab (also known as DuoBody-PD-L1x4-1BB or GEN1046/BNT311) is an investigational bispecific antibody developed by Genmab and BioNTech for cancer treatment. It is designed to elicit an antitumor immune response through two key mechanisms: Conditional activation of 4-1BB on T cells and natural killer cells PD-L1 blockade

Drug details

Arm A: GEN1046
Arm B: GEN1046 + Pembrolizumab once every 21 days
Arm C: GEN1046 + Pembrolizumab once every 42 days

Links

Clinical Trials GOV (NCT identifier): NCT05117242
EU Clinical Trials Register (eudraCT Identifier): 2021-001928-17