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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer; Neuroendocrine Cancer
• Intervention / Treatment: Biological: ZG006

• Study Type: Interventional
• Enrollment (Estimated): 265
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hewen Yin; Phone Number: +86-0512-57309965; Email: yinhw@zelgen.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai Chest Hospital
      • Principal Investigator: Shun Lu, MD
      • Contact: Shun Lu

Participation Criteria

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 18~75 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part1 ：Dose Escalation; A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg, 10 mg, and 30 mg.	Biological: ZG006; ZG006 will be administered as an intravenous (IV) infusion.
Experimental: Part2 ：Dose Expansion; Part 2 consists of three cohorts. Cohort 1 is divided into two stages: Stage 1 is for dose optimization: approximately 30 patients will be enrolled in each of the two preliminary RP2D groups; the better-performing dose will be selected for Stage 2 based on emerging data. Stage 2 is the pivotal, registrational study, intended to enroll patients with advanced small-cell lung cancer who are in third-line or later lines of therapy.	Biological: ZG006; ZG006 will be administered as an intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.	up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)		Up to approximately 2 years
Number of participants with serious adverse events (SAEs)		Up to approximately 2 years
Number of participants with adverse events (AEs)	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	Up to approximately 2 years
Duration of response (DOR)	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	Up to approximately 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Small Cell Lung Carcinoma; Carcinoma, Neuroendocrine
• Other Study ID Numbers: ZG006-002

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