A study to evaluate SYD985 in advanced or metastastic solid tumours
Research type
Research Study
Full title
A two part first-in-human phase I study (with expanded cohorts) with the antibody-drug conjugate SYD985 to evaluate the safety, pharmacokinetics and efficacy in patients with locally advanced or metastatic solid tumours
IRAS ID
159824
Contact name
Udai Banerji
Contact email
Sponsor organisation
Synthon Biopharmaceuticals BV
Eudract number
2014-001798-15
Research summary
The experimental drug SYD985 is in development for treatment of cancer patients who have the protein HER2 on their cancer cells. This research study will evaluate how safe and well tolerated SYD985 is. In addition, the level of SYD985 in the blood will be measured as well as the effect of SYD985 on the size of the cancer. This is the first time that the drug is being given to humans.
The study consists of two parts: In Part I, participants with locally advanced or metastatic solid tumours of any origin can be enrolled, whereas in Part II only participants with locally advanced or metastatic breast or gastric cancer are eligible. Participants can only participate if standard treatments are no longer working or no standard treatments exist. Participants will be recruited in 3 European countries.
In the first part of the study, different doses will be given to different participants. The first 3 participants will receive the lowest dose. If SYD985 does not cause severe side effects, a higher dose will be given to the next group of 3 to 6 participants. This will continue until the maximum tolerated dose is reached. In Part II, all participants will receive the same dose.
Participants will receive intravenous infusions with SYD985 every three weeks (one cycle) until disease progression or unacceptable side effects. During the first two cycles, participants will have to visit the clinical site at least weekly for safety assessments (e.g. blood and urine sampling, and ECGs) followed by one visit per subsequent cycle. The size of the tumour will be measured every 6 weeks. A follow-up visit is planned 30 days after the participant has stopped with the treatment.REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1485
Date of REC Opinion
1 Oct 2014
REC opinion
Further Information Favourable Opinion