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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Neuroendocrine Carcinoma

Treatments: Biological: ZG005; Drug: Etoposide; Drug: Cisplatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06372626

ZG005-004

Details and patient eligibility

About

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.

Enrollment: 93 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.

Treatment:

Drug: Cisplatin

Drug: Etoposide

Biological: ZG005

Part 2: Dose Expansion

Experimental group

Description:

Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.

Treatment:

Drug: Placebo

Drug: Cisplatin

Drug: Etoposide

Biological: ZG005