Actively Recruiting
An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Antitumor Activity of GNC-039 in Adults 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
52 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
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of GNC-039, a tetra-specific antibody, in adults with relapsed or refractory high-grade glioma or other metastatic solid tumors. This Phase 1, open-label study aims to determine the dose-limiting toxicity, maximum tolerated dose, or maximum administered dose of GNC-039 in these patients. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. and focuses on patients who have failed standard treatments and have measurable tumor lesions. Participants will receive GNC-039 through intravenous infusion. After completing the first treatment cycle, if no intolerable side effects occur, patients may continue treatment for up to eight cycles. The study includes ongoing monitoring and assessments during and after treatment to evaluate drug concentration, immune response, tumor response, progression-free survival, and overall survival. Throughout the study, participants will undergo regular safety evaluations, laboratory tests, imaging scans, and questionnaires to monitor side effects and treatment impact. The primary outcomes are dose-limiting toxicity and maximum tolerated dose within 14 days after initial dosing, with safety and effectiveness measures tracked for up to 24 months. Participants will be supported in complying with treatment plans and study visits during the trial period.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosed with recurrent high-grade glioma (WHO Grade III-IV) or other relapsed, refractory, or metastatic solid tumors after failure of standard treatment
- Karnofsky Performance Score of 60 points or higher
- Expected survival of at least 3 months as determined by researchers
- Adequate hematological function: neutrophil count ≥1.5 x10^9/L, platelet count ≥75 x10^9/L, hemoglobin ≥90 g/L
- Adequate renal function: creatinine ≤1.5 times upper limit of normal (ULN), creatinine clearance ≥50 mL/min, urinary protein ≤2+ or <1000mg/24h
- Adequate liver function: AST and ALT ≤3.0 x ULN, total bilirubin ≤1.5 x ULN (exceptions for Gilbert's syndrome)
- Adequate coagulation function: fibrinogen ≥1.5 g/L, APTT and PT ≤1.5 x ULN
- Fertile participants or partners must use highly effective contraception during and 12 weeks after treatment; negative pregnancy test for fertile females before dosing
- Ability and willingness to comply with study visits, treatment plans, and procedures
- For glioma patients: confirmed pathological diagnosis, MRI-supported recurrence, measurable tumor lesion per RANO or post-surgery recurrence, and available tumor tissue samples
- For other solid tumor patients: confirmed diagnosis with disease progression after standard treatment or inability to tolerate standard therapy, and at least one measurable lesion per RECIST v1.1
You will not qualify if you...
- Allergy to immunoglobulins or any component of GNC-039 formulation
- Active infections requiring intravenous antibiotics within 1 week prior to enrollment (except prophylactic antibiotics for biopsy)
- Positive HIV antibody, active tuberculosis, active hepatitis B or C infection
- Unresolved toxicity from prior antitumor therapy above grade 1 (except certain non-safety risks)
- Active or history of autoimmune diseases involving the central nervous system (with some exceptions)
- Severe lung disease (grade 3 or higher) or history of interstitial lung disease
- Previous organ transplant recipients
- Severe cardiovascular or cerebrovascular diseases within 6 months prior to enrollment
- Recent thrombotic events within 6 months prior to screening
- Conditions deemed unsuitable by the investigator
- For brain gliomas: recent surgery, chemotherapy, radiation, or investigational treatments within specified timeframes; recent intracranial biopsy; history of CNS bleeding or infarction
- For other solid tumors: recent chemotherapy, antibody, targeted, investigational treatments, or major surgery within specified timeframes; poorly controlled hypertension; central nervous system lesions or severe neurological diseases; recent investigational treatments not on the market
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 - Up to 8 cycles, with continuation depending on tolerance
Participants receive the study drug GNC-039 by intravenous infusion. After completing the first treatment cycle, those without intolerable side effects may continue treatment for up to 8 cycles.
Multiple visits for infusion and assessments during treatment cycles
Duration - Up to approximately 24 months
Participants are monitored for safety, adverse events, and treatment outcomes after completion of treatment.
Regular follow-up visits during the monitoring period
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
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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