Actively Recruiting
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer
Led by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Updated on 2025-11-17
265
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label Phase I/II study consisting of two parts: Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data. Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.
CONDITIONS
Official Title
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign the informed consent form
- Male or female aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced small-cell lung cancer or neuroendocrine carcinoma for Part 1
- Histologically or cytologically confirmed advanced small-cell lung cancer for Part 2
- For Part 2 Cohort 1: de-novo small-cell lung cancer (composite SCLC excluded), Stage 2 restricted to third-line or later
- For Part 2 Cohort 2: transformed small-cell lung cancer
- For Part 2 Cohort 3: large-cell neuroendocrine carcinoma of the lung and composite small-cell lung cancer
You will not qualify if you...
- Participants deemed unsuitable for the study by the 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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
H
Hewen Yin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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