SN38-SPL9111 in advanced solid tumours
Research type
Research Study
Full title
A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SN38-SPL9111 (DEP®-SN38), a SN38 dendrimer conjugate, in patients with advanced solid tumours.
IRAS ID
264996
Contact name
Natalie Cook
Contact email
Sponsor organisation
Starpharma Pty Ltd
Eudract number
2019-001318-40
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Cancer has a major impact on society and causes significant ill health in those affected by the disease. Cancers that have grown or spread within the body (known as advanced) can generally not be treated by surgery or radiotherapy and require the use of cytotoxic drugs, which work by killing cells. Cytotoxic drugs may help to slow the spread of the tumours but often cause significant side effects.\nThis research study is a phase 1/2 first-in-human study and is being conducted to determine the optimum safe dose of SN38-SPL9111 (the study drug) in participants with advanced solid tumours. First-in-human means that this research study is the first time that the study drug has been used in people.\nSN38-SPL9111 is an investigational new drug. This means it has not yet been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or any other health or regulatory authority. However, it can be used in this type of research study (known as a clinical trial).\nThe clinical trial will consist of 2 parts:\nPhase 1:\nDuring this phase, participants will receive increasing doses of the study drug. The objective of this phase of the study is to determine the maximum safe dose of the drug that does not cause intolerable side effects.\nPhase 2:\nIn this phase of the study, more participants will be given the optimum dose of the drug from phase 1. The objective of this phase of the study is to further assess potential side effects of the drug while beginning to look at how well the study drug treats advanced solid tumours.\nStarpharma Pty Ltd is the “Sponsor” of this clinical trial and is responsible for the development and oversight of the study. Around 43 participants will take part in both phases of this study at about 6 medical centres in the UK and Australia.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0188
Date of REC Opinion
7 Aug 2019
REC opinion
Further Information Favourable Opinion