Actively Recruiting
Phase I Study of HLX3901 Given by IV Infusion in Adults With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma
Led by Shanghai Henlius Biotech · Updated on 2026-07-08
138
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying HLX3901 in an open-label, first-in-human phase I clinical trial involving patients with advanced small cell lung cancer SCLC or neuroendocrine carcinoma NEC. The study aims to evaluate the safety, tolerability, and how the drug behaves in the body, focusing on patients who have experienced intolerance, recurrence, or disease progression after prior treatments. The study has two parts Phase Ia uses dose escalation and backfill cohorts where patients receive HLX3901 via intravenous infusion at increasing doses, observing dose-limiting toxicities over 4 weeks. Phase Ib expands the dose to confirm safety and efficacy of HLX3901 monotherapy in selected groups based on Phase Ia data. Participants receive the recommended Phase 2 dose RP2D identified during dose escalation. Participants will undergo screening, treatment cycles of 4 weeks, and monitoring of side effects and tumor response using objective response rates and survival measures over approximately 24 months. Safety reviews guide dosing decisions, and tumor tissue will be collected to test for DLL3 expression. The study involves regular assessments including laboratory tests and imaging to monitor health and treatment effects throughout participation, which can last up to about two years.
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 by signing informed consent
- Aged between 18 and 75 years, any gender
- Histologically or cytologically confirmed advanced small cell lung cancer or neuroendocrine carcinoma
- For small cell lung cancer, must have experienced intolerance, recurrence, or progression after platinum-based therapy combined with immune checkpoint inhibitors
- For neuroendocrine carcinoma, must have experienced intolerance, recurrence, or progression after platinum-based therapy
- At least one measurable tumor lesion within 4 weeks prior to first administration
- ECOG performance status score of 0-1 within 7 days prior to first administration
- Expected survival time greater than 3 months
- Adequate recovery time from prior therapies before first administration as specified in the protocol
- Agree to provide archived or new tumor tissue samples for DLL3 expression testing
- Adequate organ function confirmed by lab tests within 7 days prior to first administration
- Agree to use effective contraception during the study and for at least 6 months after last dose; females of childbearing potential must have negative pregnancy test within 7 days prior to enrollment
You will not qualify if you...
- History of other malignant tumors within 2 years except cured cervical carcinoma in situ or basal cell carcinoma
- Grade 2 or higher immune-related pneumonitis or myocarditis, severe immune-related adverse events from previous immunotherapy
- Significant pulmonary impairment or concurrent lung diseases
- Central nervous system diseases within 12 months prior to enrollment including seizures, cerebral hemorrhage, dementia, and others
- Active paraneoplastic syndrome
- History of hypophysitis or pituitary dysfunction
- Uncontrolled third-space effusions requiring repeated drainage
- Prior allogeneic stem cell or solid organ transplantation
- Prior exposure to therapies targeting DLL3, CD3, CD28 or antibody-drug conjugates
- Recent major surgery, chemotherapy, biologic therapy, or other treatments as specified
- Severe allergic reactions to humanized antibodies or components of the investigational product
- Active systemic infections requiring intravenous antibiotics within 2 weeks prior to first administration
- Poorly controlled cardiovascular or cerebrovascular diseases
- Active central nervous system metastases or carcinomatous meningitis except certain stable brain metastases
- Known active or suspected autoimmune diseases with specified exceptions
- Recent systemic corticosteroid or immunosuppressive therapy with exceptions
- Active tuberculosis
- History of immunodeficiency including HIV or organ transplantation
- Active HBV or HCV infection or co-infections as specified
- Received live vaccines within 28 days prior to first administration
- Pregnant or lactating women
- Any other clinical or laboratory abnormalities deemed unsuitable by the investigator
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