Clinical Trial

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.

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated April 29, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-10-03; most recent amendment 2026-04-23.
Status change: Recruiting → Active, Not Recruiting 2025-02-05
Status change: Not Yet Recruiting → Recruiting 2024-08-02
Trial Details
NCT Number NCT06074497
Lead Sponsor Kangabio AUSTRALIA LTD PTY
Conditions Advanced or Metastatic Solid Tumors
Enrollment 54 participants
Start Date 2023-12-13
Primary Completion 2026-05-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-29