NCT06283719RecruitingPhase 1/2
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
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 Advanced Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 265 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 2 Sept 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Diseases
- Neuroendocrine tumours, Lung cancer
- NCT number
- NCT06283719
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 265
- From 2 Sept 2024 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.