A Phase 1 study of ADCT-502 in patients with advanced solid tumours
Research type
Research Study
Full title
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-502 in Patients with Advanced Solid Tumors with HER2 Expression
IRAS ID
233209
Contact name
Daniel Hochhauser
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2017-001787-38
Clinicaltrials.gov Identifier
IND, 132540
Duration of Study in the UK
4 years, 3 months, 2 days
Research summary
ADCT-502 is part of a class of medicines called antibody drug conjugates (ADCs). ADCs are made up of a tumour specific antibodies attached to a medication (chemotherapy). An antibody is a protein which typically identifies and neutralises (makes ineffective) harmful substances in the body. Chemotherapy is a medication which kills cells that are rapidly dividing and growing (i.e. cancer cells).
ADCT-502 has only been tested in test tubes and animals. Studies in mice and monkeys showed that ADCT-502 was well tolerated at doses higher than the planned starting dose for this study. The potential for ADCT-502 to treat cancers that have over-expression of a protein called HER2 has been shown by complete disease responses in mice after a single, low-dose administration. It is not known if ADCT-502 will produce a similar response in humans. HER2 expression is associated with a worse disease outcome compared with tumours which did not over-express HER2, indicating the unmet medical need for a treatment.
This is a Phase 1, first-in-human (FIH), open-label study of ADCT-502 in patients with different types of solid tumour cancers with HER2 expression that will be conducted in 2 parts. Part 1 (dose-escalation) will determine the highest dose that participants can take without unacceptable side effects and the recommended dose for Part 2. Part 2 (expansion), will determine how safe and tolerable the recommended dose is in treating cancer.
This study will include male and female participants aged 18 and over. 30 participants will be enrolled in Part 1 and, depending on efficacy, up to 250 participants will be enrolled in Part 2 at study sites in Europe and the USA. The total study duration will depend on overall tolerability of the study medication but it is anticipated that it could last approximately 3 years.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/1896
Date of REC Opinion
5 Dec 2017
REC opinion
Favourable Opinion