Phase 2 study of T-DXd in Colorectal cancer (DESTINY-CRC02)
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects with HER2-Overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)
IRAS ID
293914
Contact name
Ian Chau
Contact email
Sponsor organisation
Daiichi Sankyo Inc.
Eudract number
2020-004782-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
136179, IND Number
Duration of Study in the UK
1 years, 11 months, 8 days
Research summary
Colorectal cancer (CRC) is the third most common cancer worldwide. There were approximately 1.85 million new cases diagnosed and 880,000 associated deaths worldwide in 2018. Several standard therapies for advanced or metastatic CRC (mCRC) are available. However, many patients with mCRC eventually progress on current standard of care treatments. The treatment benefit of third-line or subsequent therapy is also limited in patients who maintain a good performance status (PS) after receiving available treatments.
Daiichi Sankyo Inc. is therefore conducting this study of an investigational medicine called 'Trastuzumab Deruxtecan'. Men and women aged 18 years or over with HER2 (Human Epidermal Growth Factor Receptor 2)-positive (or “overexpressing”) colorectal cancer will be invited to take part in the study. It is expected that approximately 120 patients with HER2 “overexpressing” colorectal cancer will be enrolled into this study.
There will be two different treatment groups for this study:
Stage 1 - 40 participants will receive a 5.4 mg/Kg dose of the study drug every three weeks, and 40 participants will receive a 6.4 mg/Kg dose of the study drug every three weeks. Once 80 participants have been recruited, then the second stage of treatment will begin:
Stage 2 - 40 participants will receive a 5.4 mg/Kg dose of the study drug every three weeks.Participants will continue to receive treatment in this study as long as they are benefitting, until they experience severe side effects, their disease worsens, they withdraw consent from the study or it is decided by the study doctor or Sponsor to stop their participation. Their length of participation will vary based on health and the study events. Enrolment is planned to occur over approximately 18 months. The anticipated total duration of the study is expected to be 30 months.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0058
Date of REC Opinion
13 Apr 2021
REC opinion
Further Information Favourable Opinion