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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06283719
Other study ID # ZG006-002
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 2024
Est. completion date April 2026

Study information

Verified date May 2024
Source Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact Hewen Yin
Phone +86-0512-57309965
Email yinhw@zelgen.com
Is FDA regulated No
Health authority
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.

Study Design


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
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