NCT06283719 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
| NCT ID | NCT06283719 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 265 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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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 265 participants in total. It began in 2024-09-02 with a primary completion date of 2026-04.
⚠ 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 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.
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; * Participants with histologically or cytologically confirmed advanced solid tumors who also fulfill the following: Part 1: advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma.Part 2: advanced SCLC.Specifically for Part 2 Cohort 1: de-novo SCLC (composite SCLC excluded).Stage 2 restricted to third-line or later.Cohort 2: transformed SCLC.Cohort 3: large-cell neuroendocrine carcinoma of the lung and composite SCLC. 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 NCT06283719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Small Cell Lung Cancer. 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 NCT06283719 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 NCT06283719 currently recruiting?
Yes, NCT06283719 is actively recruiting participants. Contact the research team at yinhw@zelgen.com for enrollment information.
Where is the NCT06283719 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06283719 clinical trial?
NCT06283719 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 265 participants.
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