Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422520
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Phase 1 Study Investigating the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of BGB-C354 an Antibody-Drug Conjugate Targeting B7H3 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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 first-in-human Phase 1a1b study to evaluate the safety tolerability pharmacokinetics and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors
Study details include
The study will be conducted in 2 phases Phase 1a Monotherapy Dose Escalation and Safety Expansion and Phase 1b Dose Expansion
The visit frequency will be approximately every 21 days during study treatment
The study duration is estimated to be approximately 5 years
Study details include
The study will be conducted in 2 phases Phase 1a Monotherapy Dose Escalation and Safety Expansion and Phase 1b Dose Expansion
The visit frequency will be approximately every 21 days during study treatment
The study duration is estimated to be approximately 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-513280-11-00 | CTIS | None | None |