A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma

This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

Start Date04 Mar 2020

Sponsor / Collaborator

Eli Lilly & Co.

NCT04176016

/ TerminatedPhase 1

Safety Study of Radiolabeled (111In or 90Y) OTSA101-DTPA, an Anti-Frizzled Homolog 10 (FZD10) Monoclonal Antibody, to Evaluate Safety and Pharmacokinetics in Patients With Relapsed or Refractory Synovial Sarcoma

The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.

Start Date10 Jan 2020

Sponsor / Collaborator

OncoTherapy Science, Inc.

NCT03670069

/ TerminatedPhase 1IIT

A Pilot Study Examining the Impact of the Jak1 Inhibitor Itacitinib on the Sarcoma Tumor Immune Microenvironment

This pilot phase I trial studies how well itacitinib works in treating patients with sarcomas that do not respond to treatment (refractory) and have spread to other parts of the body (advanced/metastatic). Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Start Date30 Sep 2019

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

100 Clinical Results associated with Refractory Synovial Sarcoma

100 Translational Medicine associated with Refractory Synovial Sarcoma

0 Patents (Medical) associated with Refractory Synovial Sarcoma

Literatures (Medical) associated with Refractory Synovial Sarcoma

15 Jun 2023·International Journal of Cancer

A phase 1 trial of NY‐ESO‐1‐specific TCR‐engineered T‐cell therapy combined with a lymph node‐targeting nanoparticulate peptide vaccine for the treatment of advanced soft tissue sarcoma

Article

Author: Nagata, Yasuhiro ; Seo, Naohiro ; Kageyama, Shinichi ; Ishihara, Mikiya ; Kakunaga, Shigeki ; Miyahara, Yoshihiro ; Momose, Fumiyasu ; Takada, Kohichi ; Watanabe, Takashi ; Hattori, Hiroyoshi ; Emori, Makoto ; Kitano, Shigehisa ; Harada, Naozumi ; Muraoka, Daisuke ; Matsumine, Akihiko ; Nishida, Yoshihiro ; Endo, Makoto ; Matsumoto, Yoshihiro ; Sasada, Tetsuro ; Shiku, Hiroshi ; Sato, Eiichi ; Yamada, Tomomi ; Kawai, Akira

AbstractThe efficacy of immune checkpoint inhibitors is limited in refractory solid tumors. T‐cell receptor gene‐modified T (TCR‐T)‐cell therapy has attracted attention as a new immunotherapy for refractory cold tumors. We first investigated the preclinical efficacy and mode of action of TCR‐T cells combined with the pullulan nanogel:long peptide antigen (LPA) vaccine in a mouse sarcoma model that is resistant to immune checkpoint inhibition. Without lymphodepletion, the pullulan nanogel:LPA vaccine markedly increased the number of TCR‐T cells in the draining lymph node and tumor tissue. This change was associated with enhanced CXCR3 expression in TCR‐T cells in the draining lymph node. In the phase 1 trial, autologous New York esophageal squamous cell carcinoma 1 (NY‐ESO‐1)‐specific TCR‐T cells were infused twice into HLA‐matched patients with NY‐ESO‐1+ soft tissue sarcoma (STS). The pullulan nanogel:LPA vaccine contains an epitope recognized by TCR‐T cells, and it was subcutaneously injected 1 day before and 7 days after the infusion of TCR‐T cells. Lymphodepletion was not performed. Three patients with refractory synovial sarcoma (SS) were treated. Two out of the three patients developed cytokine release syndrome (CRS) with low‐to‐moderate cytokine level elevation. We found obvious tumor shrinkage lasting for more than 2 years by tumor imaging and long‐term persistence of TCR‐T cells in one patient. In conclusion, NY‐ESO‐1‐specific TCR‐T‐cell therapy plus vaccination with the pullulan nanogel carrying an LPA containing the NY‐ESO‐1 epitope without lymphodepletion is feasible and can induce promising long‐lasting therapeutic effects in refractory SS (Registration ID: JMA‐IIA00346).

02 Nov 2021·Expert Opinion on Therapeutic PatentsQ2 · MEDICINE

Recent updates on Wnt signaling modulators: a patent review (2014-2020)

Q2 · MEDICINE

Review

Author: Patel, Bhumika D. ; Goswami, Vishalgiri G.

Introduction: Wnt signaling is a signal transduction pathway that plays a vital role in embryonic development and normal tissue preservation. Dysfunction of it gives rise to various diseases like cancer, Alzheimer's, metabolic and skeletal disorders, kidney and liver disease, etc. Thus, targeting Wnt pathway can be a potential approach to design and develop novel therapeutic classes.Areas covered: Authors provided an overview of Wnt modulators from 2014 to 2020. Different heterocyclic scaffolds and their pharmacology from a total of 104 PCT applications have been summarized.Expert opinion: The scientific community is working extensively to bring first in the class molecule to the market which targets Wnt pathway. Lorecivivint, Wnt inhibitor, for the treatment of knee Osteoarthritis and SM-04554, Wnt activator, for the treatment of androgenetic alopecia are currently under Phase III. Other molecules, LGK-974, RXC-004, ETC-159, CGX-1321, PRI-724, CWP-232291 and BC-2059 are also under different stages of clinical development for the treatment of cancer. Antibody based Wnt modulator, OTSA101-DTPA-90Y is currently under Phase I for the treatment of Relapsed or Refractory Synovial Sarcoma while OMP-18R5 is under Phase I for Metastatic Breast Cancer. Ongoing preclinical/clinical trials will define the role of the Wnt pathway in different therapeutic areas and open new opportunities.

01 Dec 2019·Clinical and Translational Oncology

Anlotinib inhibits synovial sarcoma by targeting GINS1: a novel downstream target oncogene in progression of synovial sarcoma

Article

Author: Shen, Z ; Yu, W ; Wang, Y ; Tang, L ; Li, H

BACKGROUNDSynovial sarcoma (SS) is an aggressive soft-tissue sarcoma with a poor prognosis owing to its resistance to radiation and chemotherapy. Thus, novel therapeutic strategies for SS are urgently required. Anlotinib, a new oral tyrosine kinase inhibitor, is designed to primarily inhibit multi-targets in vasculogenesis and angiogenesis. This study was designed to characterize its antitumor efficacy and possible mechanism in patients with advanced refractory synovial sarcoma.METHODSAnlotinib's antitumor effect was evaluated in vivo and vitro. Downstream targets of anlotinib in treating synovial sarcoma were analyzed through microarray assay. Cell proliferation and apoptosis analyses were performed to evaluate the impact of candidate downstream gene depletion in synovial sarcoma cells. Microarray assay were carried out to investigate potential signal network related with candidate downstream gene.RESULTSAnlotinib significantly suppresses synovial sarcoma proliferation in PDTX model and cell lines. Additionally, GINS1 (also named as PSF1, Partner of SLD Five 1), rather than other conventional gene target, was demonstrated to be a vital target of anlotinib's antitumor effect in synovial sarcoma through microarray assay. Expression of GINS1 was remarkably higher in synovial sarcoma tumor samples and related with poor outcome. Knockdown of GINS1 expression could remarkably inhibit proliferation and promote apoptosis in vitro. Meanwhile, through microarray assay, CITED2, EGR1, SGK1 and SPP1 were identified and further validated by qPCR/WB as downstream targets of GINS1.CONCLUSIONAnlotinib might suppress proliferation of SS through a novel downstream GINS1-regulated network which plays a vital function in SS proliferation and also demonstrated that targeting the GINS1-regulated signal pathway could be a potential strategy for management of SS.

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