U3-1402 in patients with advanced or metastatic colorectal cancer
Research type
Research Study
Full title
A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects with Advanced or Metastatic Colorectal Cancer (CRC)
IRAS ID
284774
Contact name
Daniel Hochhauser
Contact email
Sponsor organisation
DAIICHI SANKYO, INC
Eudract number
2019-004418-32
Clinicaltrials.gov Identifier
148299, IND
Duration of Study in the UK
2 years, 1 months, 29 days
Research summary
Summary of Research
Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer death worldwide. Metastatic CRC is when the cancer has spread from the original tumour to other parts of the body. Fewer than 20% of patients with metastatic CRC are expected to survive 5 years.
There are currently limited effective options for patients who have progressed on approved standard treatments, therefore there is a great unmet medical need in advanced or metastatic CRC.
U3-1402 is a new drug that has been designed to bring chemotherapy inside HER3-positive cancer cells and kill them. HER3 is a protein in the body that is thought to cause cancer cells to grow.
The purpose of this study is to see whether U3-1402 has any effect on slowing tumour growth and how well it is tolerated in patients with advanced or metastatic CRC who have not responded to previous cancer treatments.
Participants will be treated with U3-1402 every 3 weeks via intravenous infusion (directly in to a vein), until discontinuation.
Approximately 80 participants are expected to participate in this study worldwide.
Summary of Results
Preparation of plain language summary of study results is pending.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/1029
Date of REC Opinion
30 Oct 2020
REC opinion
Further Information Favourable Opinion