Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

Neuroendocrine Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372626
• Other study ID #: ZG005-004
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 30, 2024
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Cheng Wei
• Phone: +8651257309965
• Email: weic[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: August 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma

Intervention

Biological:
• ZG005
ZG005 for dose escalations are set as 10mg/kg, 20mg/kg, and the other doses after discussion. intravenous infusion, once every 3 weeks. ZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Drug:
• Etoposide
IV infusion
• Cisplatin
IV infusion
• Placebo
0.9% Sodium Chloride Injection

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity (DLT)		Up to 2 years
Primary	Objective Response Rate (ORR)	ORR was defined as the percentage of the participants in the analysis population who have a Complete Response or a Partial Response. The ORR per RECIST 1.1 as assessed by Investigator is presented	Up to 2 years
Primary	Adverse Event (AE)	Number of participants with adverse events that are related to treatment	Up to 2 years