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

NCT06372626 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2024-06-14

No results posted yet for this study

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.

Conditions

  • Neuroendocrine Carcinoma

Interventions

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

DRUG

Cisplatin

IV infusion

DRUG

Placebo

0.9% Sodium Chloride Injection

Sponsors & Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jason Wu · Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2026-07-31
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372626 on ClinicalTrials.gov