Actively Recruiting
A Phase I, Open Label, Multi-center Study to Assess the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
Led by Kangabio AUSTRALIA LTD PTY · Updated on 2026-04-24
57
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates advanced or metastatic solid tumors in patients who have not responded to standard treatments. It is a phase I, open-label, multi-center study designed to explore the safety and tolerability of the drug KGX101 alone and in combination with Envafolimab in Chinese patients. The study also aims to determine the recommended dose for phase 2 of KGX101 both as a monotherapy and combined with Envafolimab. Participants will receive KGX101 either alone or alongside Envafolimab every three weeks. The study involves dose escalation and expansion phases with different dose levels of KGX101 monotherapy and combination therapy. KGX101 is given as an injection, and Envafolimab is a subcutaneous injection. The dosing schedule includes about 6 to 8 visits in the first month, followed by visits approximately every three weeks thereafter. During the study, participants will attend clinic visits for various checkups and tests, including monitoring for adverse events and laboratory abnormalities. Researchers will assess tolerability, dose-limiting toxicities, drug pharmacokinetics, immune response, and tumor responses using criteria such as RECIST 1.1. Follow-ups will continue every 90 days after treatment to evaluate progression-free and overall survival. The study duration extends from the first dose until up to 90 days after the last dose, including safety monitoring.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Confirmed diagnosis of a solid tumor that is locally advanced or metastatic and has failed standard treatments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Adequate organ and bone marrow function, including hemoglobin > 90 g/L, platelet count ≥ 100 x 10e9/L, and absolute neutrophil count ≥ 1.5 x 10e9/L
- Life expectancy of at least 3 months
- Signed and dated informed consent prior to any study procedures
You will not qualify if you...
- Active second malignancy except treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, or breast cancer
- Primary central nervous system (CNS) malignancies
- Severe or uncontrolled systemic diseases, including active infection, hypertension, or chronic wounds
- Active autoimmune diseases requiring systemic treatment in the last 2 years or immunodeficiency on immunosuppressive or chronic steroid therapy
- History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis/interstitial lung disease
- Unresolved toxicities from prior therapy greater than grade 1 according to CTCAE 5.0
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until 21 days post the first target dosing
Participants receive KGX101 monotherapy or combination therapy with Envafolimab to assess safety and tolerability of the drugs.
Visits according to dosing schedule during treatment period
Duration - Up to 90 days after the last dose and survival follow-up every 90 days post last treatment
Participants are monitored for safety, immunogenicity, and survival outcomes after treatment ends.
Follow-up visits every 90 days post treatment
Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Fudan university Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
3
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
J
Jun Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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