Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05145569
Status:
WITHDRAWN
Last Update Posted:
2025-01-01
First Post:
2021-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antitumor Activity of Neoadjuvant Chemotherapy with or Without HCW9218 in Metastatic Advanced Stage Ovarian Cancer
Sponsor:
Haider Mahdi
Organization:
Study Overview
Official Title:
A Phase 2 Open-label Study to Assess the Antitumor Activity of Neoadjuvant Chemotherapy with or Without HCW9218 in Patients with Metastatic Advanced Stage Ovarian Cancer
Status:
WITHDRAWN
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per PI and agent sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the safety, tolerability, and anti-tumor activity of HCW9218 in combination with chemotherapy will be assessed in patients with advanced stage ovarian cancer undergoing neoadjuvant chemotherapy.
Detailed Description:
Existing data supports a potential role and synergistic activity between TGF-β inhibitors and PD1 TGF-β has been investigated in ovarian cancer and it is suggested to play a dominant role as a potent inducer of ovarian cancer invasiveness and metastasis in additional studies \[36\]. In fact, TGF-β ligand and TGF-β receptor I and II are strongly expressed in ovarian tumors especially high-grade ovarian cancers. Further, TGF-β is abundantly secreted into the tumor microenvironment by cancer and stromal cells in this cancer. TGF-β expression has been shown to significantly higher in ovarian cancer tissue especially advanced stage disease compared to healthy tissue or borderline tumors. Inhibiting senescence in the immune compartment may have a profound effect on the cytotoxic functions of both innate and adaptive immune cells. This study aims to examine markers of senescence on immune cells obtained from blood throughout the proposed trial. We hypothesize that HCW9218 will act as a senolytic by "trapping" excess TGF-β, therefore inhibiting its ability to promote senescence. We believe that this combined with the immune activating effect of IL-15 will be a biologically relevant therapeutic with potential to at least partially reverse therapy induced senescence (TIS) or in the future, perhaps have an effect even on physiologic aging.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: