Actively Recruiting
A Phase II Study to Evaluate the Safety and Efficacy of SKB571 in Patients With Advanced Non-Small Cell Lung Cancer
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-12
295
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SKB571, an investigational drug, in a multicenter phase II study for patients with advanced non-small cell lung cancer. The study aims to assess the safety and early anti-tumor effects of SKB571 in this population. Eligible participants have locally advanced or metastatic disease and measurable tumors. Participants will receive SKB571 as a monotherapy injection every three weeks. Treatment continues until disease progression seen on scans, intolerable side effects, patient choice to stop, or other protocol-defined reasons. This study does not include placebo or other comparison treatments. During the study, patients will undergo regular monitoring including imaging scans to evaluate tumor response and safety assessments. Researchers will track adverse events and measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and disease control rate up to 24 months. The study lasts until treatment stops or progression occurs, with close follow-up for up to two years.
CONDITIONS
Brief Title
A Phase II Study of SKB571 in Patients With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
- At least one measurable tumor lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of 12 weeks or more as assessed by investigator
- Adequate organ function
- Recovery from all toxicities from prior therapies
- Agreement to use highly effective contraception during study treatment
- Voluntary signing of informed consent form
You will not qualify if you...
- Known active or untreated central nervous system metastases
- Other malignant tumors within 3 years before first dose
- History of major cardiovascular, cerebrovascular, or thromboembolic disease
- HIV infection or active viral hepatitis B or C
- Uncontrolled pleural, pericardial, or ascites effusion needing repeated drainage
- Known allergy or hypersensitivity to SKB571 or its excipients
- Clinically severe lung injuries from pulmonary complications
- History or current noninfectious pneumonitis or interstitial lung disease requiring steroids
- Major surgery within 28 days prior to first dose
- Live vaccines within 30 days before first dose or planned during study
- Use of strong CYP3A4 or BCRP inhibitors or inducers within 2 weeks prior or 5 half-lives of drug
- Chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to first dose
- Active infection requiring systemic anti-infective therapy within 14 days prior
- Systemic corticosteroids or immunosuppressive therapy within 14 days prior to first dose
- Any condition interfering with safety assessment or study results interpretation as per investigator opinion
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 - Until disease progression or discontinuation
Participants receive SKB571 for injection every 3 weeks until radiographic disease progression, intolerable toxicity, or other protocol-specified discontinuation criteria occur.
Visits every 3 weeks for injections
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
2
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
X
Xin Li
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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