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NCT Number: NCT06283719

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

This is a multicenter, open-label Phase I/II study consisting of two parts:

Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data.

Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.

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Key information

Conditions

Small Cell Lung Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Neuroendocrine Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Cancer Neuroendocrine Tumors Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Shun Lu

CONTACT

Shun Lu, MD

PRINCIPAL_INVESTIGATOR

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 18~75 years of age;
  • Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥ 3 months;
  • Participants with histologically or cytologically confirmed advanced solid tumors who also fulfill the following: Part 1: advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma.Part 2: advanced SCLC.Specifically for Part 2 Cohort 1: de-novo SCLC (composite SCLC excluded).Stage 2 restricted to third-line or later.Cohort 2: transformed SCLC.Cohort 3: large-cell neuroendocrine carcinoma of the lung and composite SCLC.

Exclusion criteria

  • Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Treatment and study plan

ZG006

Biological

ZG006 will be administered as an intravenous (IV) infusion.

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: up to approximately 2 years

    ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 2 years

    The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 2 years

  3. Duration of response (DOR)

    Time frame: Up to approximately 2 years

    DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause

  4. Disease control rate (DCR)

    Time frame: Up to approximately 2 years

Study contacts

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

Hewen Yin

CONTACT

[email protected]

+86-0512-57309965

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Nov 17, 2025

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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