Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283719
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-21
Brief Title:
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
Sponsor:
Suzhou Zelgen Biopharmaceuticals CoLtd
Organization:
Suzhou Zelgen Biopharmaceuticals CoLtd
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter open-label phase III 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None