Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789069
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-02-24
Brief Title:
A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors
Sponsor:
HiFiBiO Therapeutics
Organization:
HiFiBiO Therapeutics
Study Overview
Official Title:
A Phase 1a1b Open-Label Multi-Center Dose Escalation and Expansion Study of HFB200603 Anti-BTLA Antibody as a Single Agent and in Combination With Tislelizumab Anti-PD-1 Antibody in Adult Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-11
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:
The purpose of this study is to test the safety and tolerability of HFB200603 as a single agent and in combination with tislelizumab in patients with advanced cancers There are two parts in this study During the escalation part groups of participants will receive increasing doses of HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined During the expansion part participants will take the doses of HFB200603 as a monotherapy optional arm or in combination with tislelizumab that were determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have
Detailed Description:
This is a Phase 1ab first in human open-label dose escalation and expansion study in adults with advanced cancers The study will comprise of
1 A Screening Period of up to 28 days
2 A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 21 days Number of cycles depends on how the disease responds to the study drug
3 A Follow-up Period which involves 2 visits
1 A Screening Period of up to 28 days
2 A Treatment Period during which participants will receive the study drug on the first day of each cycle where each cycle is 21 days Number of cycles depends on how the disease responds to the study drug
3 A Follow-up Period which involves 2 visits
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