NCT06440057 Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
| NCT ID | NCT06440057 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Condition | Neuroendocrine Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2024-08-29 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2024-08-29 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, open-label phase I/II study, divided into 2 parts: Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2. Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.
Eligibility 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.
Contact & Investigator
Jason Wu
STUDY CHAIR
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Frequently Asked Questions
Who can join the NCT06440057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Neuroendocrine Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06440057 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06440057 currently recruiting?
Yes, NCT06440057 is actively recruiting participants. Contact the research team at ningsd@zelgen.com for enrollment information.
Where is the NCT06440057 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06440057 clinical trial?
NCT06440057 is sponsored by Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The principal investigator is Jason Wu at Suzhou Zelgen Biopharmaceuticals Co.,Ltd. The trial plans to enroll 78 participants.