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.

A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation Trial of KGX101 Monotherapy and in Combination with Envafolimab in Patients with Advanced or Metastatic Solid Tumors.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Kangabio AUSTRALIA LTD PTY · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will enrol 54 participants depending on the number of dose escalations needed. The study has 2 parts- Part A monotherapy dose escalation and Part B combination dose escalation. This study will assess KGX101 monotherapy (Part A) and in combination therapy with Envafolimab (Part B) by a standard 3+3 dose escalation design to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D). This study schedule will include a 28-day screening, a DLT observation period, followed by variable length study treatment period, 90-day safety follow-up after the last treatment, and survival follow-up every 90 days. Therefore, the total duration of participation will vary for each participant depending on total doses. A priming dose is the initial lower dose(s) followed by escalation to the full treatment dose(s). Priming dose will be implemented in all cohorts. As the first 3 enrolled previously participants at 0.003 mg/kg didn't receive priming dose, the subsequent enrolled patients at this dose level will receive two priming doses before the target dose. Two priming doses of KGX101 with an dosing interval of 10 days will be recommended. Priming dose regimen may be adjusted by Dose Escalation Committee (DEC) based on the real-time safety, available PK and PD data. The participants will receive KGX101 intravenous infusion at assigned escalating dose alone or in combined with 400mg Envafolimab every 3 weeks until disease progression or discontinuation criterion is met.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-13
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2023-10-10
• Last updated: 2025-02-07

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study