Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336707
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-20
Brief Title:
HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors
Sponsor:
Hansoh BioMedical RD Company
Organization:
Hansoh BioMedical RD Company
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
HS-20089 is an investigational antibody-drug conjugate ADC composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker with an average drug-to-antibody ratio of about 6
This is a phase Ⅰ open-label multi-center study to evaluate the safety tolerability pharmacokinetics PK and efficacy of HS-20089 in combination with other antitumor agents Adebrelimab with or without platinum Bevacizumab with or without platinum in subjects with advanced solid tumors
This is a phase Ⅰ open-label multi-center study to evaluate the safety tolerability pharmacokinetics PK and efficacy of HS-20089 in combination with other antitumor agents Adebrelimab with or without platinum Bevacizumab with or without platinum in subjects with advanced solid tumors
Detailed Description:
This study contains four combination therapy cohorts each consisting of a dose exploration part and a dose expansion part
The dose exploration part will explore the corresponding optimal dose level of HS-20089 in each combination therapy The dose expansion part will be conducted at 1 or 2 safe and potentially effective dose levels in subjects with selected tumors in each cohort
The cohorts may be adjusted based on the observed clinical results translational medicine data and research progress in the field
The dose exploration part will explore the corresponding optimal dose level of HS-20089 in each combination therapy The dose expansion part will be conducted at 1 or 2 safe and potentially effective dose levels in subjects with selected tumors in each cohort
The cohorts may be adjusted based on the observed clinical results translational medicine data and research progress in the field
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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