Testing ZG006 for advanced small cell lung cancer and neuroendocrine carcinoma
A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
This study is testing a new drug called ZG006 to see if it is safe and effective for people with advanced small cell lung cancer or neuroendocrine carcinoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06440057 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study is divided into two parts. The first part focuses on dose escalation to assess the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma. Following this, the second part will expand on the recommended doses to evaluate the efficacy and safety of ZG006 specifically in patients with neuroendocrine carcinoma. The study aims to gather important pharmacokinetic data alongside preliminary efficacy results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced small cell lung cancer or neuroendocrine carcinoma and an ECOG performance status of 0 or 1.
Not a fit: Patients who are not suitable for participation as determined by the investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced neuroendocrine carcinoma.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in targeting neuroendocrine tumors with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form; * Male or female 18\~75 years of age; * Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1; * Life expectancy ≥ 3 months. Exclusion Criteria: * Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shangdi Ning
- Email: ningsd@zelgen.com
- Phone: +86-0512-57309965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.