NCT04601402

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

A Phase I/Ib Study to Evaluate the Safety, Tolerability, Biological and Clinical Activities of GEN-001 in Combination With Avelumab in Patients With Advanced Solid Tumors Who Have Progressed During or After Treatment With Anti-PD-(L)1 Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Genome & Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Non Small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	GEN-001	The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10\^11 colony-forming units (CFU)
DRUG	Avelumab	800 mg given by intravenous (IV) infusion once every 2 weeks

Timeline

• Start date: 2020-10-26
• Primary completion: 2023-01-11
• Completion: 2023-01-11
• First posted: 2020-10-23
• Last updated: 2023-08-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study