Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545331
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Study of XB010 in Subjects With Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Dose-Escalation and Expansion Study of XB010 as a Single Agent and Combination Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a FIH study is to evaluate the safety tolerability PK immunogenicity and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective
Detailed Description:
This study consists of Dose-Escalation and Cohort-Expansion Stages The Dose-Escalation Stage is designed to determine the maximum tolerated dose MTD andor recommended dosages for expansion RDEs of XB010 as a single agent and to evaluate XB010 monotherapy RDEs in combination with pembrolizumab The Cohort-Expansion Stage is designed to explore the clinical activity and further characterize the safety and tolerability of XB010 as monotherapy in multiple tumor-specific cohorts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None