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

Phase 1

Recruiting

• Conditions: Neuroendocrine Cancer; Small Cell Lung Cancer
• Interventions: Biological: ZG006

• Registration Number: NCT06283719
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

This is a multicenter, open-label phase I/II study, divided into 2 parts:

Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.

Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-28
• Study Start: 2024-09-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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;

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Expansion	ZG006	Participants will receive the RP2D identified in Dose exploration of the study.
Dose Escalation	ZG006	A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg, 10 mg, and 30 mg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China