drugset / Trial / NCT04601402

GEN-001 (Live Biotherapeutic Product) and Avelumab Combination Study for Patients With Solid Tumors Who Have Progressed on Anti-PD-(L)1 Therapy

NCT04601402

NaSequentialOpen-labelTreatment

Summary

This is a phase I/Ib, first-in-human (FIH), open-label, dose escalation and dose expansion study to evaluate the safety and tolerability, biological and clinical activities of GEN-001 in patients with locally advanced or metastatic solid tumors who have progressed on at least two lines of approved therapy for their histological subtypes which includes an anti-PD-1 or anti-PD-L1 based therapy (as mono or combination), when administered as combined with avelumab.

Timeline

Start
2020-10-26
Primary completion
2023-01-11
Completion
2023-01-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 800 mg Intravenous
Subject GEN-001 Other / unclassified 1e+11 unknown Oral