Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer

NCT07231445 | Recruiting Phase 1

• 1 other identifier: ZG006-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Dose-limiting toxicities (DLTs)

  Up to Day 28

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Up to 2 Years

Secondary Outcomes (3)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 2 Years

• Maximum Serum Concentration (Cmax) of ZG006

  Up to 2 Years

• Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006

  Up to 2 Years

Study Arms (2)

Part 1：Group A

EXPERIMENTAL

ZG006 Q3W

Drug: ZG006; Drug: Serplulimab

Part 1：Group B

EXPERIMENTAL

ZG006 Q3W

Drug: ZG006; Drug: Serplulimab

Interventions

Serplulimab DRUG

Serplulimab will be administered as an IV infusion.

Part 1：Group A; Part 1：Group B

ZG006 DRUG

ZG006 will be administered as an IV infusion.

Part 1：Group A; Part 1：Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with histologically or cytologically confirmed ES-SCLC.
• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Cong Zhang

CONTACT

17602176888; zhangc@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: April 21, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

CN (1)