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NCT Number: NCT06372626

Study 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.

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Key information

Conditions

Neuroendocrine Carcinoma Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Jianming Xu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZG005

Biological

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.

etoposide

Drug

IV infusion

Cisplatin

Drug

IV infusion

Placebo

Drug

0.9% Sodium Chloride Injection

Primary outcomes

  1. Dose Limiting Toxicity (DLT)

    Time frame: Up to 2 years

  2. 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

  3. Adverse Event (AE)

    Time frame: Up to 2 years

    Number of participants with adverse events that are related to treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Wei

CONTACT

[email protected]

+8651257309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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