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

NCT ID: NCT06283719

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-02
• Study Completion Date: 2026-04-30

Brief Summary

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.

Conditions

Small Cell Lung Cancer; Neuroendocrine Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ZG006

Intervention Type: BIOLOGICAL

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

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.

Group Type: EXPERIMENTAL

ZG006

Intervention Type: BIOLOGICAL

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

Interventions

ZG006

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hewen Yin

Role: CONTACT

yinhw@zelgen.com

+86-0512-57309965

Facility Contacts

Shun Lu

Role: primary

Other Identifiers

ZG006-002

Identifier Type: -

Identifier Source: org_study_id