Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06223256
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-12-18
Brief Title:
A Study of NBL-028 in Patients With Advanced Solid Tumors
Sponsor:
NovaRock Biotherapeutics Ltd
Organization:
NovaRock Biotherapeutics Ltd
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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 multi-center single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 CLDN6 for whom standard of care therapies are not available are no longer effective or not tolerated This study consists two stages dose-escalating and dose-expansion
Dose escalation will be guided by the Bayesian optimal interval BOIN design including accelerated titration to determine the maximum tolerated dose MTD of NBL-028 Dose expansion - Additional patients no more than 200 will be enrolled at the recommended dose or multiple doses if necessary determined in the dose escalation stage Sponsor may elect to enroll specific tumor types into four cohorts
Dose escalation will be guided by the Bayesian optimal interval BOIN design including accelerated titration to determine the maximum tolerated dose MTD of NBL-028 Dose expansion - Additional patients no more than 200 will be enrolled at the recommended dose or multiple doses if necessary determined in the dose escalation stage Sponsor may elect to enroll specific tumor types into four cohorts
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