Clinical trial · Interventional
Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With 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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.
- interventionNames
- Biological: ZG005
- Drug: Etoposide
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
- interventionNames
- Biological: ZG005
- Drug: Etoposide
- Drug: Cisplatin
- Drug: Placebo
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available