Phase 1, First-in-Human Study of DS-9606a in Patients with Tumor Types Expressing Claudin-6
Research type
Research Study
Full title
A Phase 1, First-in-Human Study of DS-9606a in Patients with Tumour Types Known to Express Claudin-6 (CLDN6)
IRAS ID
1004591
Contact name
Eric Richards
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2022-000120-38
Clinicaltrials.gov Identifier
Research summary
This is a study to investigate the safety and tolerability of the study drug, DS-9606a, in patients with advanced cancer. The study is will recruit patients at sites in the UK, the United States, and Japan.
DS-9606a is experimental and not yet approved by any regulatory bodies. Patients will receive DS-9606a by slow intravenous infusion once every 21 days. The study protocol may be amended to change the dosing frequency to once every 28 days. Patients will undergo frequent physical examinations and blood specimens will be collected to assess the affects of the drug.
This research study is important because the results may help establish new treatments that result in improved outcomes for patients with cancer. Participants may continue to receive the drug in 21 or 28-day cycles as long as their doctor believes that there is some clinical benefit, but participants may withdraw at any time of their own choosing.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0218
Date of REC Opinion
5 May 2022
REC opinion
Further Information Favourable Opinion