Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540066
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Study of BGB-B3227 Alone and in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open-label Phase 1a1b Study to Investigate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activity of BGB-B3227 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
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 first-in-human FIH open-label multicenter dose escalation and expansion study of BGB-B3227 a humanized immunoglobulin G1 IgG1 antibody The purpose of this study is to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics and preliminary antitumor activity of BGB-B3227 as a monotherapy or in combination with tislelizumab with or without chemotherapy in participants with selected advanced or metastatic solid tumors The study will also identify recommended doses for expansion RDFEs of BGB-B3227 administered alone and in combination with tislelizumab
Detailed Description:
None
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