MedTrace Logo

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients

NCT07260305 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-04-24

No results posted yet for this study

Summary

This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

KGX101 injection

KGX101 is a heterodimeric IL-12 prodrug with the C-terminus of IL-12 fused with ADCC-impaired IgG1 Fc and the N-terminus of IL-12 masked using the IL-12 binding domains of IL-12Rβ1 and IL-12Rβ2. KGX101 injection is a sterile, white or white-like lyophilized powder, supplied at 4.0 mg/vial for single use.

DRUG

Envafolimab

Envafolimab is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment formulated for subcutaneous injection.

Sponsors & Collaborators

  • Kangabio AUSTRALIA LTD PTY

    lead INDUSTRY

Principal Investigators

  • Jun Guo · Beijing Cancer Hopspital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2027-01-01
Completion
2027-03-30

Countries

  • China

Study Locations

More Related Trials

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 NCT07260305 on ClinicalTrials.gov