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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.

NCT06074497 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-29

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Kangabio AUSTRALIA LTD PTY

    lead INDUSTRY

Principal Investigators

  • Weidong Jiang, Dr · Chief Executive Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-13
Primary Completion
2026-05-30
Completion
2028-05-30
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06074497 on ClinicalTrials.gov