Testing ZG006 for advanced small cell lung cancer and neuroendocrine carcinoma
Official title: 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.
Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT06440057 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 29, 2024 |
| Main results expected | May 2026 |
| Study ends | July 2026 |
| Registry record updated | December 16, 2024 |
| Trial ID | NCT06440057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are not suitable for participation as determined by the investigator will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is being explored in this specific context, similar studies have shown promise in targeting neuroendocrine tumors with novel therapies.
Who can join: the full rules
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 it's running
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Shangdi Ning
- Email: ningsd@zelgen.com
- Phone: +86-0512-57309965
Similar studies
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ZG006 plus ZG005 for advanced small cell lung cancer and neuroendocrine carcinoma
This trial tests whether the combination of ZG006 and ZG005 helps adults with advanced small cell lung cancer or neuroendocrine carcinoma.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.