A dose-escalation and dose-expansion study of ADCT-901 in patients with solid tumours
Research type
Research Study
Full title
A Phase 1, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 as Monotherapy in Patients with Selected Advanced Solid Tumors
IRAS ID
1005842
Contact name
Sabine Soldan
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2021-002292-19
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1, multi-centre, open-label study with two parts consisting of a dose-escalation and a dose expansion part; it will enroll approximately 76 adult participants equal to or over 18 years old. Anti-tumor activity of ADCT-901 has been observed in preclinical studies. This is the first study in which ADCT-901 is being given to humans. The purpose of this study is to understand the best and safe dose level of ADCT-901 to treat participants with advanced malignancies. ADCT-901 is an antibody-drug conjugate (ADC), a type of medicine that combines an antibody (a protein that binds to specific substances in the body) with a chemotherapy drug that can kill cells. The antibody part helps direct the chemotherapy to cancer cells, and kill them. The study will include a screening period, a treatment period and a follow-up period for up to 1 year after the end of treatment. Participants will receive treatment in cycles of 3 weeks as long as needed and/or tolerated. In the dose escalation part, the first three patients will start at a low dose. Each new dose is thereafter increased after at least 3 patients have been dosed with no severe side effects. This dose escalation continues until a dose is identified as the dose to be used in the expansion part. ADCT-901 will be given as an intravenous (IV) infusion over 30 minutes on Day 1 of each cycle. The response to the treatment will be assessed by radiographic tumour assessments and tumour biomarkers. A Dose Escalation Steering Committee (DESC) will be responsible for safety monitoring and overall supervision of the study. The following study procedures will be performed: (a) physical examinations (b) ECGs (c) blood tests, (d) urine tests (e) tumor scans (f) tumour tissue collection (g) IV Infusion (h) questionnaires.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0246
Date of REC Opinion
21 Nov 2022
REC opinion
Further Information Favourable Opinion