Condition: Solid Tumor Malignancies · Clear Cell Endometrial Carcinoma · Ovarian Cancer · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Rational, objective and design: Some cancer-protecting genes are inactivated when the EZH2 enzyme is too active or the SWI/SNF complex is less active. The EZH1/2 enzymes and the SWI/SNFs complex play opposing roles in gene expression: we hypothesize that valemetostat, an inhibitor of the EZH1/2 enzymes, will stop/slow down the growth of cancer cells by reactivating these genes. Numerous clinical trials are currently underway worldwide to optimize the development of valemetostat tosylate and potentially offer a new targeted therapeutic option for patients suffering from various cancer pathologies. The aim of this research is to evaluate the efficacy of valemetostat on solid tumors, which have an alteration in certain genes: SMARC (B1/A4/A2/C1/C2), ARID (1A/1B), PBRM1, BAP1 and other SWI/SNF sub-units. The research will be conducted in two phases: 1) Pre-selection of patients with the desired alterations. 2) Treatment with valemetostat, 200mg/day, for a maximum of 2 years, with examinations every 28 days. This is a multicenter, international, phase II open-label, multicenter modular study exploring the efficacy and safety of valemetostat. Module 1 will be the SWI/SNF basket monotherapy study describe below. Such design will allow the study to evolve considering signals for further monotherapy and/or combination modules. The Primary endpoint of the study is Overall Response Rate at 24 weeks, defined as the proportion of patients with a confirmed best overall response. Trial …
This description comes directly from the study's public registry record.
Sophie Postel-Vinay, MD, PhD · +33142114343 · SOPHIE.POSTEL-VINAY@gustaveroussy.fr
Always discuss trial participation with your own doctor first.
| Gustave Roussy | Villejuif, Val de Marne, France | Recruiting |
| Institut Bergonié | Bordeaux, France | Not Yet Recruiting |
| Centre Léon Berard | Lyon, France | Not Yet Recruiting |
| Institut Curie | Paris, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07303387