Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05765851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-11
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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 evaluate the safety and efficacy of DS-1103a combination therapy in patients with advanced solid tumors.
Detailed Description:
DS-1103a, a recombinant humanized IgG4 anti-SIRPĪ± antibody designed to block the SIRPĪ±-CD47 interaction, is being developed for the treatment of advanced cancers in combination with other anticancer therapies. This is the first-in-human, dose-escalating clinical study designed to assess the safety and efficacy of DS-1103a combination therapy in patients with advanced solid tumors.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-503965-48-00 | OTHER | EU CT | View |