This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors.

Phase 1 Active not recruiting 54 enrolled Kangabio AUSTRALIA LTD PTY

Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic solid tumors.

Timeline

Start: 2023-12-13
Primary completion: 2026-05-30
Completion: 2028-05-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Envafolimab	Monoclonal antibody	400 mg	Subcutaneous
Comparator	Envafolimab	Monoclonal antibody	600 mg	Subcutaneous
Subject	KGX101	Protein / enzyme biologic	0.1 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	0.3 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	1 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	2 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	3 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	5 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	6 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	12 ug/kg	Intravenous
Subject	KGX101	Protein / enzyme biologic	15 ug/kg	Intravenous

Indications

No indication recorded.