Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427941
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-20
Brief Title:
A Phase 1 Study of BGB-B2033 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 1 Study Investigating the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activity of BGB-B2033 Alone or in Combination With Tislelizumab in Participants With Selected 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a first-in-human FIH Phase 1 study of BGB-B2033 to assess the safety tolerability pharmacokinetics PK pharmacodynamics and preliminary antitumor activity of the BGB-B2033 in participants with advanced or metastatic hepatocellular carcinoma HCC alpha-fetoprotein AFP-producing gastric cancer GC extragonadal yolk sac tumors non-dysgerminomas or glypican-3 GPC3-positive squamous non-small cell lung cancer NSCLC The study will also identify the recommended Phase 2 dose RP2D of BGB-B2033 alone and in combination with tislelizumab for subsequent studies BGB-B2033 will be administered by intravenous infusion The Phase 1 study will be conducted in 2 parts Part A Monotherapy Dose Escalation and Safety Expansion and Part B Combination Dose Escalation and Safety Expansion
Detailed Description:
None
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