NCT06074497View on ClinicalTrials.gov

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.

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

May 30, 2026

Study Completion Date

May 30, 2026

Conditions
Advanced or Metastatic Solid Tumors
Interventions
DRUG

KGX101- Cohort -1

Single dose of 0.1, 0.3, 1μg/kg of KGX101 every 3 weeks

DRUG

KGX101- Cohort 1

Single dose of 0.3, 1.0, 3.0μg/kg of KGX101 every 3 weeks

DRUG

KGX101- Cohort 2

Single dose of 1, 1 and 3μg/kg of KGX101 every 3 weeks

DRUG

KGX101- Cohort 3

Single dose of 1,3 and 6μg/kg of KGX101 every 3 weeks

DRUG

KGX101- Cohort 4

Single dose of 1,3,12μg/kg of KGX101 every 3 weeks

DRUG

KGX101- Cohort 5

Single dose of 2, 5 and 15 μg/kg of KGX101 every 3 weeks

DRUG

KGX101 and Envafolimab

Part B combination therapy KGX101 with Envafolibmab. 400mg to be injected subcutaneously with each target dose of KGX101 every 3 weeks. The dose escalation committee (DEC) may decide to increase the dosage to 600mg. based on PK, PD and safety data.

Trial Locations (3)

3199

Peninsula & South Eastern Haematology and Oncology Group, Frankston

4217

Pindara Private Hospital, Benowa

4575

Sunshine Coast University Private Hospital, Birtinya

All Listed Sponsors
lead

Kangabio AUSTRALIA LTD PTY

INDUSTRY

NCT06074497 - 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. | Biotech Hunter | Biotech Hunter