Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05360680
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-04-19
Brief Title:
A Phase 1 in Patients With HLA-A0201 and WT1 RecurrentMetastatic Cancers
Sponsor:
Cue Biopharma
Organization:
Cue Biopharma
Study Overview
Official Title:
A Phase 1 Open-Label Dose Escalation and Expansion Study of CUE-102 Monotherapy in HLA-A0201 Positive Patients With WT1 Positive RecurrentMetastatic Cancers
Status:
ACTIVE_NOT_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 is a Phase 1 open-label 2-part multi-center study evaluating the safety tolerability PK pharmacodynamics PD immunogenicity and antitumor activity of CUE-102 intravenous IV monotherapy in HLA-A0201 positive patients with WT1 positive recurrentmetastatic solid tumors who have failed conventional therapies
Detailed Description:
CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies by selective engagement and expansion of tumor antigen-specific T cells that should allow for increased potential for anti-cancer efficacy and reduced toxicity relative to non-targeted forms of immunotherapy that result in systemic activation of the immune system
The goal of Part A is to characterize the safety tolerability and biological effects of CUE-102
The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A and to evaluate antitumor activity at this dose
The goal of Part A is to characterize the safety tolerability and biological effects of CUE-102
The goal of Part B is to expand the safety and immune activity data at the RP2D identified in Part A and to evaluate antitumor activity at this dose
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