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

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283719
• Other study ID #: ZG006-002
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Hewen Yin
• Phone: +86-0512-57309965
• Email: yinhw[@]zelgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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;

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Lung Neoplasms
• Neuroendocrine Cancer
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.	up to approximately 2 years
Secondary	Number of participants with adverse events (AEs)	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	Up to approximately 2 years
Secondary	Number of participants with serious adverse events (SAEs)		Up to approximately 2 years
Secondary	Duration of response (DOR)	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	Up to approximately 2 years
Secondary	Disease control rate (DCR)		Up to approximately 2 years