ADC-1013 First-in-Human Study
Research type
Research Study
Full title
A first-in-human, multicenter, open-label, multiple ascending dose Phase I study in patients with advanced solid tumors to determine the safety, pharmacokinetics and pharmacodynamics of intratumorally or intravenously administered ADC-1013
IRAS ID
170506
Contact name
Dan Palmer
Contact email
Sponsor organisation
Alligator Bioscience AB
Eudract number
2014-004556-56
Duration of Study in the UK
2 years, 8 months, 7 days
Research summary
This study of the drug ADC-1013 is sponsored by Alligator Bioscience AB. ADC-1013 has been developed to treat cancer by a process called immunotherapy by targeting a protein called CD40 present on the surface of cells. CD40 has been found to play an important role in balancing the immune system whilst also killing off cancer cells. Studies of other drugs that target CD40 have shown that this is a potentially important pathway to target for treating cancer.
ADC-1013 is a new experimental drug and this trial will be the first time ADC-1013 has been given to humans. ADC-1013 will be given by injections directly into tumours. The intention is to reduce acute systemic exposure and hence decrease the risk of acute reactions such as cytokine release syndrome (which has been seen with other similarly acting drugs). Injecting the drug directly into tumours has been used with other immune activating drugs such as IL-2 and was associated with an improved safety profile.
This study investigates whether ADC-1013 will be safely administered and tolerated in patients receiving it as repeated injections directly into the cancer tissue. The study will be conducted in two parts. The first part (dose escalation) will recruit patients in groups of 3 to explore different dose levels that will be carefully increased in a step-wise manner. The second part (dose expansion) will recruit up to 10 patients at a fixed dose level and will provide more information about the safety, tolerability and clinical effectiveness of ADC-1013. Approximately 40 patients in at least 5 hospitals in the UK, Sweden and Denmark will be recruited. The main objective of the study is to understand the safety and tolerability of ADC-1013. As part of the study procedures patients will need to undergo regular blood tests and repeat tumour biopsies for evaluation.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0011
Date of REC Opinion
29 Jan 2015
REC opinion
Favourable Opinion