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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuroendocrine Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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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.

Intervention Type BIOLOGICAL

Etoposide

IV infusion

Intervention Type DRUG

Cisplatin

IV infusion

Intervention Type DRUG

Placebo

0.9% Sodium Chloride Injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No