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

June 13, 2024 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
          • Jianming XU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation
Dose-escalation study of ZG005 in combination with Etoposide and Cisplatin.
Drug: Cisplatin
IV infusion
Drug: Etoposide
IV infusion
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.
Experimental: Part 2: Dose Expansion
Group A: ZG005 in combination with Etoposide and Cisplatin; Group B: Placebo in combination with Etoposide and Cisplatin.
Drug: Cisplatin
IV infusion
Drug: Etoposide
IV infusion
Drug: Placebo
0.9% Sodium Chloride Injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicity (DLT)
Time Frame: Up to 2 years
Up to 2 years
Objective Response Rate (ORR)
Time Frame: Up to 2 years
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
Adverse Event (AE)
Time Frame: Up to 2 years
Number of participants with adverse events that are related to treatment
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Study Chair: Jason Wu, Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZG005-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe