Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05394675
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-05-24
Brief Title:
A Study of DS-9606a in Patients With Advanced Solid Tumors
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 First-in-Human Study of DS-9606a in Patients With Tumor Types Known to Express Claudin-6 CLDN6
Status:
RECRUITING
Status Verified Date:
2024-07
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 will assess the safety and tolerability of DS-9606a in patients with advanced solid tumors
Detailed Description:
This first-in-human phase 1 study will consist of 2 parts In Part A Dose Escalation the primary objectives will be to investigate the safety and tolerability of DS-9606a in advanced solid tumors and to determine the maximum tolerated dose MTD and recommended dose for expansion RDE In Part B Dose Expansion the safety and tolerability of DS-9606a will be further explored and the overall response rate will be assessed
The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a and assess the immunogenicity of DS-9606a
The secondary objectives of the study will assess pharmacokinetic properties of DS-9606a and investigate the duration of response and progression-free survival of DS-9606a and assess the immunogenicity of DS-9606a
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 |
|---|---|---|---|
| 2022-000120-38 | EUDRACT_NUMBER | None | None |
| REFMAL 823 | OTHER | Sarah Cannon Development Innovations LLC | None |