CDK-002-101 exoSTING in cancer

• Research type

  Research Study

• Full title

  A First-in-Human Study of CDK-002 (exoSTING) in Subjects with Advanced/Metastatic, Recurrent, Injectable Solid Tumours, with Emphasis on Squamous Cell Carcinoma of the Head and Neck, Triple Negative Breast Cancer, Anaplastic Thyroid Carcinoma, and Cutaneous Squamous Cell Carcinoma

• IRAS ID

  279818

• Contact name

  Kevin Harrington

• Contact email

  kevin.harrington@icr.ac.uk

• Sponsor organisation

  Codiak BioSciences, Inc.

• Eudract number

  2020-000752-34

• Clinicaltrials.gov Identifier

  NCT04592484

• Clinicaltrials.gov Identifier

  Central Portfolio Management System (CPMS), 45689

• Duration of Study in the UK

  1 years, 7 months, 15 days

• Research summary

  Patients who have advanced solid tumours that cannot be removed by surgery, or have tumours that are recurrent or progressing since their last antitumour therapy, for which no alternative standard therapy exists will be invited to participate in the study.
  Before a potential participant enters the study, they will be given information to make an informed choice. If they wish to proceed, a consent form will be signed by the participant and study doctor.
  This is a first-in-human study meaning that participants in the study will be the first humans to receive the CDK-002 study drug.

  The study drug being tested is called CDK-002. It is injected directly into the tumour in a bubble like particle called an ‘exosome’. Once the CDK-002 is inside the tumour, it attracts immune system cells to attack the tumour, potentially killing the cancer cells.
  The study will be spilt into two parts. Part A, dose escalation, will investigate the best dose of CDK-002 to be used. The second part, dose expansion,Part B, participants will be treated with the best dose from Part A in order to further study how well CDK-002 is tolerated and how active it is against certain cancers.
  Each participant will receive a weekly injection for 3 weeks, with a break for one week. Then they will receive an injection every two weeks for 4 weeks and then one injection every 4 weeks.

  All study assessments including the study drug injection will take place at a hospital under the supervision of the study doctor, the research team and medically qualified individuals.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  20/SC/0357

• Date of REC Opinion

  31 Dec 2020

• REC opinion

  Further Information Favourable Opinion