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 Advanced Small Cell Lung Cancer
This study is testing a new treatment called ZG006 to see if it is safe and effective for people with advanced small cell lung cancer and neuroendocrine carcinoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 265 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06283719 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study consists of two parts: a dose-escalation phase and a dose-expansion phase. In Part 1, the safety and tolerability of ZG006 will be assessed in patients with advanced small cell lung cancer or neuroendocrine carcinoma, leading to the determination of recommended doses for Part 2. The second part will focus on evaluating the efficacy and safety of ZG006 in a larger group of patients with advanced small cell lung cancer.
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 deemed unsuitable for participation by the investigator or have a life expectancy of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced small cell lung cancer and neuroendocrine carcinoma.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in targeting advanced small cell lung cancer 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; * 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hewen Yin
- Email: yinhw@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.