ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma

Phase 1

Not yet recruiting

• Conditions: Small Cell Lung Cancer; Neuroendocrine Carcinoma
• Interventions: Drug: ZG006; Drug: ZG005

• Registration Number: NCT07038096
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-08-01
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Fully understand the study and voluntarily sign the informed consent form.
• Male or female 18-70 years of age.
• Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
• Eastern Cooperative Oncology Group (ECOG) 0 to 1.
• Life expectancy > 3 months.

Exclusion Criteria

• The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase Ib: Part1-Dose Escalation	ZG006	This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
Phase Ib: Part1-Dose Escalation	ZG005	This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
Phase Ib: Part2-Dose Expansion	ZG006	The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
Phase Ib: Part2-Dose Expansion	ZG005	The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
Phase II	ZG006	Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.
Phase II	ZG005	Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)	up to 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to 2 years
Objective Response Rate (ORR)	Up to 2 years	The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to 2 years
Overall Survival (OS)	Up to 2 years
Duration of Response (DOR)	Up to 2 years
Disease Control Rate (DCR)	Up to 2 years