Actively Recruiting
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21
20
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with Locally advanced or metastatic non-small cell lung cancer and other solid tumors.
CONDITIONS
Official Title
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Any gender
- Age 18 years or older (up to 75 years for Stage Ia; no upper age limit for Stage Ib)
- Diagnosed with locally advanced or metastatic non-small cell lung cancer or other solid tumors
- At least one measurable lesion meeting RECIST v1.1 criteria
- Archived primary or recurrent tumor tissue available for central review
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 3 months as judged by investigators
- Adequate bone marrow, kidney, and liver function
- Coagulation function within specified limits (fibrinogen ≥1.5g/L; APTT ≤1.5× upper limit of normal; PT ≤1.5× upper limit of normal)
- Fertile participants or partners agree to use effective contraception from 7 days before first dose to 12 weeks after last dose; females of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Able and willing to comply with all study visits, treatments, laboratory tests, and procedures
You will not qualify if you...
- Use of chemotherapy, biological therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral fluorouracil
- Active infection requiring intravenous antibiotics not completed within 1 week before enrollment
- Positive HIV antibody, active tuberculosis, or active hepatitis B or C virus infection
- Toxicity from previous anti-cancer therapy not reduced to grade 1 or meeting inclusion criteria
- Risk of or history of autoimmune disease affecting the central nervous system
- Severe pulmonary disease (grade 3 or higher), history of interstitial lung disease requiring steroids, current interstitial lung disease, or grade 2 or higher radiation pneumonitis
- Previous allogeneic stem cell or organ transplantation
- History of severe cardiovascular or cerebrovascular disease
- Thrombotic events within 6 months before screening (deep vein thrombosis, arterial thrombosis, pulmonary embolism)
- Brain or meningeal metastases or spinal cord compression, except stable and asymptomatic brain metastases
- Uncontrolled pleural effusion with symptoms
- Poorly controlled high blood pressure (systolic >150 mmHg or diastolic >100 mmHg)
- Participation in clinical trial of unmarketed drug within 4 weeks before trial dose
- Receipt of live vaccine within 4 weeks before trial dose
- Other conditions deemed inappropriate by investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, 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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