Actively Recruiting
Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
Led by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Updated on 2026-01-05
54
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.
CONDITIONS
Official Title
Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign the informed consent form
- Male or female 18 to 75 years of age
- Histologically or cytologically confirmed diagnosis of small cell lung cancer or neuroendocrine carcinoma with no standard treatment available or intolerant to standard treatments
- Archival or fresh biopsy tissue sample available for DLL3 detection
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Must have evaluable or measurable lesion; lesions previously treated with radiotherapy must show progression
- All prior treatment adverse events returned to baseline or are Grade 1 or less, except non-safety risk events
- Female and male patients must agree to use reliable contraception during and for 6 months after treatment
You will not qualify if you...
- Prior treatment with anti-DLL3 and anti-CD3 drugs, chemotherapy, biotherapy, endocrine therapy (except hormone replacement), or biological targeted medicines within 4 weeks before study entry
- Local palliative radiotherapy or small molecule targeted therapy within 2 weeks or 5 half-lives before study entry
- Systemic immunosuppressive medications (corticosteroids >10 mg/day prednisone equivalent) within 14 days before study entry
- Use of any viral vaccines within 4 weeks of study entry
- Blood transfusion, EPO, G-CSF, albumin infusion, or renal replacement therapy within 14 days before study entry
- Main organ function abnormalities within 7 days prior including low blood counts, elevated liver enzymes, low albumin, impaired kidney function, or abnormal blood clotting
- Presence of central nervous system metastases unless stable
- Uncontrollable third cavity effusions requiring repeated drainage
- Any other malignancy within 5 years except certain removed or non-recurrent tumors
- Severe cardiovascular disease including recent myocardial infarction, unstable angina, stroke, heart failure NYHA class II-IV, low left ventricular ejection fraction, or uncontrolled hypertension
- Prolonged QTc interval >480 ms
- History of autoimmune diseases except certain controlled conditions
- Active infections including hepatitis B/C, syphilis, HIV
- Active neurologic paraneoplastic syndrome
- Interstitial lung disease or non-infectious pneumonitis excluding radiation-induced pneumonia
- Prior allogeneic stem cell or solid organ transplantation
- Known allergy to monoclonal antibodies or antibody excipients
- Diagnosed neurological or mental disorders such as epilepsy or dementia
- Pregnant or nursing females
- Deemed unsuitable by investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
H
Hewen Yin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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