Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
Led by Shanghai Henlius Biotech · Updated on 2026-04-29
138
Participants Needed
2
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
CONDITIONS
Official 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 study details and provide informed consent
- Aged 18 to 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 first dose
- ECOG performance status 0-1 within 7 days before first dose
- Expected survival greater than 3 months
- Adequate recovery from prior treatments and specific time intervals since last therapies before first dose
- Agree to provide or undergo tumor tissue biopsy for DLL3 expression testing
- Adequate organ function confirmed by labs within 7 days before first dose
- Use effective contraception if of child-bearing potential and negative pregnancy test if female of childbearing age
You will not qualify if you...
- History of other cancers within 2 years except certain cured cancers
- Significant immune-related lung or heart conditions or severe immune reactions from prior immunotherapy
- Clinically significant lung diseases or recent pulmonary embolism
- Central nervous system diseases within 12 months including seizures, strokes, or severe brain injury
- Active paraneoplastic syndrome or pituitary dysfunction
- Uncontrolled fluid build-up requiring drainage
- Prior organ or stem cell transplant
- Recent treatment with therapies targeting DLL3, CD3, CD28 or recent major surgery or chemotherapy
- Severe allergies to antibodies or related substances
- Active infections needing IV antibiotics or active tuberculosis
- Poorly controlled cardiovascular conditions or abnormal heart function
- Active or untreated brain metastases with exceptions for stable, treated cases
- Active autoimmune diseases except controlled hypothyroidism or type 1 diabetes
- Recent use of systemic corticosteroids or immunosuppressants
- History of immunodeficiency or organ transplantation
- Active hepatitis B or C infections or co-infections
- Recent live vaccinations
- Pregnant or lactating women
- Other clinical or lab abnormalities deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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