Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06283719

Recruiting

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

Interventional

Phase 1/2

Shanghai Chest Hospital

Sponsor: Zelgen Biopharmaceuticals

Last Updated: November 17, 2025

Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

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.

Treatment Category

Other Drugs

Required Mutations

None

Trial Started

September 2, 2024

Last Updated by Sponsor

November 17, 2025

Estimated Completion

April 1, 2026

Contact Study

Name:Hewen Yin

Email:yinhw@zelgen.com

Phone:+86-0512-57309965

Eligibility

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.

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingNone (Open Label)

Number to Enroll265

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg, 10 mg, and 30 mg.

Interventions:

ZG006

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR)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 Outcome Measures

Disease control rate (DCR)Up to approximately 2 years

Number of participants with adverse events (AEs)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

Number of participants with serious adverse events (SAEs)Up to approximately 2 years

Duration of response (DOR)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

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Trial Sites

This study has 1 trial site

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, CN

Name:Shun Lu

Recruiting

Shanghai, Shanghai Municipality, CN

Shanghai Chest Hospital

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