Actively Recruiting
A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-29
60
Participants Needed
6
Research Sites
293 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
S
SystImmune Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this study, the safety, tolerability and preliminary effectiveness of GNC-039 in patients with relapsed/refractory or metastatic glioma or other solid tumors will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-039.
CONDITIONS
Official Title
A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed recurrent high-grade glioma (WHO Grade III-IV) or other recurrent/refractory or metastatic solid tumors after failure of standard treatment
- No gender limitation
- Age 18 years or older
- Karnofsky Performance Score (KPS) of 60 points or higher
- Expected survival of at least 3 months as determined by researchers
- Adequate hematological function: neutrophil count ≥1.5x10⁹/L, platelet count ≥75x10⁹/L, hemoglobin ≥90g/L
- Adequate renal function: creatinine ≤1.5 times upper limit normal (ULN), creatinine clearance ≥50 mL/min, urinary protein ≤2+ or <1000mg/24h
- Adequate liver function: AST and ALT ≤3.0 times ULN, total bilirubin ≤1.5 times ULN (with exceptions for Gilbert's syndrome)
- Adequate coagulation function: fibrinogen ≥1.5 g/L, APTT ≤1.5 times ULN, PT ≤1.5 times ULN
- Use of highly effective contraception for fertile females and males with fertile partners from consent until 12 weeks after last dose; negative pregnancy test for fertile females before dosing
- Ability and willingness to comply with study visits, treatment, and procedures
- For glioma patients: confirmed pathological diagnosis, MRI-supported recurrence, at least one measurable tumor lesion or surgical treatment after recurrence, and available tumor tissue samples for review (or approval to enroll without tissue)
- For other solid tumor patients: histologic or cytologic confirmation of recurrent/refractory or metastatic solid tumors with progression after standard treatment or intolerance/contraindication to standard therapy; at least one measurable lesion per RECIST v1.1
You will not qualify if you...
- Allergy to immunoglobulin or any component of GNC-039
- Active infections needing intravenous antibiotics not completed at least 1 week before enrollment (except prophylactic antibiotics for biopsy)
- Positive HIV antibody, active tuberculosis, active hepatitis B or C infection
- Toxicities from prior anti-tumor therapy not resolved to grade 1 or less (with some exceptions)
- Active autoimmune diseases or history of autoimmune diseases affecting the central nervous system, with some exceptions
- Severe lung disease (grade 3 or higher), resting dyspnea, continuous oxygen therapy, or history of interstitial lung disease
- Previous organ transplant recipients
- Severe cardiovascular or cerebrovascular diseases within 6 months prior to study
- Thrombotic events within 6 months before screening
- Conditions deemed unsuitable by investigator
- For brain glioma patients: recent surgery, chemotherapy, radiation, biopsy, or investigational drugs within specified times before enrollment; history of CNS bleeding or infarction within 6 months
- For other solid tumor patients: recent chemotherapy, antibody, targeted therapy, investigational drugs, or major surgery within specified times; poorly controlled hypertension; previous CNS lesions or severe brain disorders; recent investigational treatments not on market
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
2
Affiliated Cancer Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
4
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
5
The First Affiliated Hospital of Xi'an Jiao Tong University
Xian, Shanxi, China
Actively Recruiting
6
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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