Ignite Creation Date:
2024-05-06 @ 2:00 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04180371
Status:
RECRUITING
Last Update Posted:
2023-07-17
First Post:
2019-11-19
Brief Title:
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
Sponsor:
BicycleTx Limited
Organization:
BicycleTx Limited
Study Overview
Official Title:
Phase III Study of the Safety Pharmacokinetics and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression
Status:
RECRUITING
Status Verified Date:
2024-09
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 clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2 The main goals of this study are to
Find the recommended doses of BT5528 that can be given safely to participants alone and in combination with nivolumab
Learn more about the side effects of BT5528
Learn about how effective BT5528 is for the treatment of ovarian cancer urothelialbladder cancer lung cancer NSCLC triple-negative breast cancer head and neck cancer HNSCC and gastricupper gastrointestinal cancer
Learn more about BT5528 therapy alone and in combination with nivolumab
Find the recommended doses of BT5528 that can be given safely to participants alone and in combination with nivolumab
Learn more about the side effects of BT5528
Learn about how effective BT5528 is for the treatment of ovarian cancer urothelialbladder cancer lung cancer NSCLC triple-negative breast cancer head and neck cancer HNSCC and gastricupper gastrointestinal cancer
Learn more about BT5528 therapy alone and in combination with nivolumab
Detailed Description:
BT5528 consists of a bicyclic peptide Bicycle which binds to EphA2 and is covalently attached to a spacer and a protease cleavable peptide linker attached to MMAE
The Phase III multi-center open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine recommended Phase II doses RP2D Following selection of a recommended Phase II doses RP2D a dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528
The Phase III multi-center open-label trial will evaluate BT5528 administered once-weekly as a single agent and in combination with nivolumab The Phase I portion is a dose escalation primarily designed to assess the safety and tolerability of BT5528 and to determine recommended Phase II doses RP2D Following selection of a recommended Phase II doses RP2D a dose expansion portion will be initiated with the primary objective of evaluating the clinical activity of BT5528
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