Actively Recruiting
Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of HLX3901 in Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma
Led by Shanghai Henlius Biotech · Updated on 2026-04-29
138
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating HLX3901, a new drug given by intravenous infusion, in adults with advanced small cell lung cancer or neuroendocrine carcinoma. This early phase I trial aims to assess the safety, tolerability, and how the drug moves through the body. The study includes patients who have experienced disease progression or intolerance to prior platinum-based therapies, sometimes combined with immune checkpoint inhibitors for small cell lung cancer. The study consists of two parts: Phase Ia uses an accelerated dose escalation and 3 + 3 dose escalation method to find the right dose of HLX3901, with seven planned dose levels and a backfill cohort enrolling 2 to 3 dose groups. The dose-limiting toxicity observation period lasts 4 weeks after the first drug administration. Phase Ib expands the dose group to further explore safety and effectiveness at the recommended dose identified in Phase Ia. Participants will be monitored closely throughout the study which can last up to about 24 months. Researchers will assess dose-limiting toxicities, maximum tolerated dose, and objective response rate, along with secondary measures such as adverse events, duration of response, progression-free survival, and overall survival. Regular laboratory tests, imaging, and tumor tissue analyses will be conducted, with safety reviewed by a committee to guide dose recommendations.
CONDITIONS
Brief Title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily agree to participate with signed consent
- Aged between 18 and 75 years, any gender
- Confirmed advanced small cell lung cancer or neuroendocrine carcinoma with prior platinum-based therapy failure
- At least one measurable tumor lesion within 4 weeks before treatment
- ECOG performance status of 0-1 within 7 days before treatment
- Expected survival longer than 3 months
- Sufficient recovery time from recent treatments before starting study drug
- Agree to provide or undergo biopsy for tumor tissue testing
- Adequate organ function confirmed by recent lab tests
- Agree to use effective contraception during and 6 months after study if of childbearing potential; negative pregnancy test for women of childbearing age
You will not qualify if you...
- History of other cancers within 2 years except certain cured types
- Severe immune-related lung or heart conditions from prior immunotherapy
- Significant lung disease or autoimmune diseases involving lungs
- Central nervous system diseases or severe brain conditions within 12 months
- Active paraneoplastic syndrome or pituitary disorders
- Uncontrolled fluid build-up requiring repeated drainage
- Prior allogeneic stem cell or organ transplant
- Recent treatments including DLL3/CD3/CD28 therapies or antibody-drug conjugates
- Severe allergic reactions to similar antibodies or drug components
- Active infections needing IV antibiotics recently
- Poorly controlled heart or cerebrovascular diseases
- Active brain metastases except stable or small asymptomatic cases under monitoring
- Known active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Recent systemic corticosteroid or immunosuppressive treatment
- Active tuberculosis or immunodeficiency conditions including HIV
- Active hepatitis B or C infections not meeting viral load criteria
- Recent live vaccinations
- Pregnant or breastfeeding women
- Any other conditions making participation unsuitable as judged by investigators
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 - Repeated 28-day cycles; initial dose-limiting toxicity observation lasts for 4 weeks after first dose; treatment may continue up to approximately 24 months.
Participants receive HLX3901 via intravenous infusion during dose escalation, backfill, or dose expansion stages to evaluate safety, tolerability, and pharmacokinetics.
Visits occur during each 4-week treatment cycle; frequency may vary depending on dose group and study phase
Duration - Up to approximately 24 months
Participants are monitored for safety, efficacy, and survival outcomes after completing treatment with HLX3901.
Visits scheduled periodically during follow-up up to 24 months
Trial Site Locations
Total: 2 locations
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
2
Shanghai Chest Hospital
Shanghai, China
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here