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Spots Global Cancer Trial Database for Antitumor Activity of Neoadjuvant Chemotherapy With or Without HCW9218 in Metastatic Advanced Stage Ovarian Cancer

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Trial Identification

Brief Title: Antitumor Activity of Neoadjuvant Chemotherapy With or Without HCW9218 in Metastatic Advanced Stage Ovarian Cancer

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

Study ID: NCT05145569

Conditions

Ovarian Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Contact Details

Name: Haider S Mahdi, MD

Affiliation: UPMC Hillman Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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