CPI-0209 in Patients with Advanced Tumors

• Research type

  Research Study

• Full title

  A Phase 1/2 Study of CPI-0209 in Patients with Advanced Solid Tumors and Lymphomas

• IRAS ID

  287576

• Contact name

  Harriet Walter

• Contact email

  hw191@leicester.ac.uk

• Sponsor organisation

  Constellation Pharmaceuticals, Inc.

• Eudract number

  2020-004952-14

• Clinicaltrials.gov Identifier

  NCT04104776

• Duration of Study in the UK

  1 years, 6 months, days

• Research summary

  The aim of this study is to look at a novel drug called CPI-0209 and how effective it is in treating a variety of malignancies. Potential participants will have been treated with standard treatments but are no longer responding and their disease is now growing again.
  Studies have shown that CPI-0209 inhibits a gene called EZH2 (Enhancer of Zeste Homolog 2) which is thought to play a role in the development of many different types of cancers. CPI-0209 turns the EZH2 gene off and may be able to stop or slow down cancer.
  The protocol consists of Phase 1 and Phase 2. In the United Kingdom, only Phase 2 Monotherapy will be undertaken. The following tumour types will form part of the study - urothelial carcinoma, ovarian clear cell carcinoma, endometrial carcinoma, germinal centre B-cell like diffuse large B-cell lymphoma (GCB-DLBCL), malignant pleural or peritoneal mesothelioma, and metastatic castration-resistant prostate cancer (mCRPC). Phase 2 (Monotherapy in disease-specific cohorts) will last approximately 18 months after the initiation of each respective
  cohort Phase 2 patients will be followed for survival approximately every 3 months for up to 24 months from the first dose of study drug or up to 12 months after treatment discontinuation (whichever is longer).
  The efficacy of CPI-0209 will be measured by looking at biomarkers in blood samples, tumour biopsies and fluid arising because of the cancers in the participants.
  In brief, participants will have the following study procedures performed on you: (a) questionnaires, (b) tumour biopsies, (c) blood tests, (d) physical examinations, (e) CT/PET scans, MRI, (f) study drug in the form of tablets, (g) ECGs, (h)bone scans

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/LO/0579

• Date of REC Opinion

  19 Oct 2021

• REC opinion

  Further Information Favourable Opinion