Actively Recruiting
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
Led by Kangabio AUSTRALIA LTD PTY · Updated on 2026-04-24
57
Participants Needed
3
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit
- Eastern Cooperative Oncology Group performance status of 0-1
- At least 1 measurable lesion per RECIST 1.1
- Adequate organ and bone marrow function including hemoglobin > 90 g/L, platelet count ≥100×10e9/L, and absolute neutrophil count ≥1.5×10e9/L
- Life expectancy of at least 3 months
- Signed and dated informed consent prior to any study-related procedures
You will not qualify if you...
- Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, or breast cancer
- Primary central nervous system malignancies
- Severe or uncontrolled systemic diseases including active infection, hypertension, or chronically unhealed wounds or ulcers
- Active autoimmune disease requiring systemic treatment in the last 2 years
- Immunodeficiency on immunosuppressive therapy or chronic systemic or enteric steroid therapy
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
- Unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1
AI-Screening
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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
CONTACT
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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