NCT03829501

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Kymab Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.

Conditions

• Squamous Cell Carcinoma of Head and Neck
• Non-small Cell Lung Cancer
• Hepatocellular Carcinoma
• Esophageal Cancer
• Gastric Cancer
• Melanoma
• Renal Cell Carcinoma
• Pancreatic Cancer
• Cervical Cancer
• Triple Negative Breast Cancer
• Advanced Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Alomfilimab	A human anti-ICOS monoclonal antibody
DRUG	Atezolizumab	An anti-PD-L1 monoclonal antibody

Timeline

• Start date: 2019-01-28
• Primary completion: 2024-10-03
• Completion: 2024-10-03
• First posted: 2019-02-04
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

22 sites across 6 countries: United States, Hungary, Italy, Poland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study