Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 9:29 AM
Study NCT ID:
NCT04672434
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
Sponsor:
Symphogen A/S
Organization:
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:
COMPLETED
Status Verified Date:
2024-12
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 \[MAD\]) and/or the selected dose(s) 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) and/or the selected dose(s) 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) and/or the selected dose(s) 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:
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?: