Combining ZG005 with Etoposide and Cisplatin for Advanced Neuroendocrine Carcinoma
A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
This study is testing if a new treatment combining ZG005 with two existing cancer drugs can help people with advanced neuroendocrine carcinoma feel better and manage their disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06372626 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of ZG005 in combination with Etoposide and Cisplatin for patients with advanced neuroendocrine carcinoma. It consists of two parts: the first part focuses on dose escalation to determine the tolerability of the treatment, while the second part expands on this by evaluating the preliminary efficacy and safety of the combination. Participants will receive either the treatment or a placebo, and the study aims to gather data on how well this combination works in managing the disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed recurrent or metastatic neuroendocrine carcinoma and an ECOG performance status of 0-1.
Not a fit: Patients with central nervous system metastases or other malignancies within the past 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced neuroendocrine carcinoma.
How similar studies have performed: While there is limited information on similar studies, the combination of chemotherapy agents with novel treatments like ZG005 is an area of ongoing investigation, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fully understand the study and voluntarily sign the informed consent form. * Male or female 18-70 years of age. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. * Histologically confirmed recurrent or metastatic neuroendocrine carcinoma * Life expectancy ≥ 3 months. Exclusion Criteria: * Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases; * Any other malignancy within 5 years. * participants were deemed unsuitable for participating in the study by the investigator for any reasons.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Cheng Wei
- Email: weic@zelgen.com
- Phone: +8651257309965
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.