Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04672434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2020-12-07
Brief Title:
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
Sponsor:
Symphogen AS
Organization:
Symphogen AS
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter Trial Investigating the Safety Tolerability and Preliminary Antineoplastic Activity of Sym024 Anti-CD73 as Monotherapy and in Combination With Sym021 Anti-PD-1 in Patients With Advanced Solid Tumor Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
The primary purpose of this study is to see if Sym024 is safe and tolerable as monotherapy and in combination with Sym021 in patients with solid tumor malignancies
Detailed Description:
Part 1 of this study will assess the safety and tolerability to establish the maximum tolerated dose MTD or the maximum administered dose MAD andor the selected doses of Sym024 in patients with solid tumor malignancies
Part 2 of this study will assess the safety and tolerability to establish the MTD or the MAD andor the selected doses of Sym024 when administered in combination with Sym021 in patients with solid tumor malignancies
Part 2a of this study will assess the safety and tolerability of Sym024 when first administered as a single agent during Cycle 1 safety lead-in followed by administration in combination with Sym021 during Cycle 2 and subsequent cycles
Part 3 of this study will assess the safety of Sym024 when administered alone or in combination with Sym021 in expanded cohorts of patients with solid tumor malignancies
April 2024 The above was the study design at trial start Per protocol implementation of a part 3 would require an amendment However this was never done as it was decided not to include a part 3
Part 2 of this study will assess the safety and tolerability to establish the MTD or the MAD andor the selected doses of Sym024 when administered in combination with Sym021 in patients with solid tumor malignancies
Part 2a of this study will assess the safety and tolerability of Sym024 when first administered as a single agent during Cycle 1 safety lead-in followed by administration in combination with Sym021 during Cycle 2 and subsequent cycles
Part 3 of this study will assess the safety of Sym024 when administered alone or in combination with Sym021 in expanded cohorts of patients with solid tumor malignancies
April 2024 The above was the study design at trial start Per protocol implementation of a part 3 would require an amendment However this was never done as it was decided not to include a part 3
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