NCT04925947

A Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors

Phase II Study of KN046 in Patients With Thymic Carcinoma Who Failed Immune Checkpoint Inhibitors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of the study drug KN046 in patients with advanced thymic carcinoma who progressed after prior treatment with immune checkpoint inhibitor therapy.

Detailed description

Patients will receive KN046 intravenously at 5 mg/kg every 2 weeks until progression or excessive toxicity for up to to two years, with the goal of this trial to contribute to the development of active and well tolerated treatments for patients who have progressed on prior treatment therapies. Recently, molecules that combine PD-1 and CTLA-4 have been developed for patients with lung cancer, with the hope that targeted therapy will be more effective than standard of care therapies. KN046 is believed to be less toxic than other targeted therapies with an assumption that the whole molecule can actively target tumor tissue for a much higher affinity of the anti-PD-L1 portion and a weaker affinity for anti-CTLA-4, leading to less autoimmune disorders and toxicities for patients than seen with other targeted therapies.

Conditions

• Thymic Carcinoma

Interventions

Type	Name	Description
DRUG	KN046	KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2021-06-14
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study