ADCT-301-103: study of ADCT-301 in selected advanced solid tumours
Research type
Research Study
Full title
A Phase 1b, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) as Monotherapy or in Combination in Patients With Selected Advanced Solid Tumors.
IRAS ID
1003602
Contact name
Sabine Soldan
Sponsor organisation
ADC Therapeutics SA
Eudract number
2019-003132-23
Clinicaltrials.gov Identifier
Research summary
This research study is designed to evaluate the safety of the investigational medication camidanlumab tesirine in combination with pembrolizumab in order to identify a recommended dosing regimen(s) in patients. Male and female participants aged 18 years of age and older with selected Advanced Solid Tumours will be eligible for this study. This study will be done at about 10 research centres globally and include approximately 95 participants in total.
Approximately 40 participants will have already tested camidanlumab tesirine alone in the study in the initial portion of the study.
The UK sites will only take part in the combination (camidanlumab tesirine in combination with pembrolizumab) portion of the study.
This portion of the study consists of 2 parts:
• Part 1: The purpose of the first part of this study is to find the highest and/or the recommended dosing regimen(s) that can be safely taken by participants while showing some preliminary signs of efficacy.
• Part 2: The second part is designed to determine if the recommended dosing regimen(s) identified in part 1 continue to be safe and show preliminary signs of efficacy in more participants.The Study Doctor will let participants know whether they will participate in Part 1 or 2. The course of treatment will be the same for Part 1 or Part 2.
For each participant the study includes a Screening Period (up to 21 days), a Treatment Period (cycles of 3 weeks), and a Follow-Up Period (approximately every 12 weeks visits for up to 1 year after the last dose of camidanlumab tesirine or the last dose of pembrolizumab, whichever is the latest). The total amount of time participants are in the study will depend on how they tolerate the study medication and if their cancer responds well to the treatment.
Participants will undergo a range of different procedures including physical examinations, sample collection, and radiological exams.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0110
Date of REC Opinion
19 May 2021
REC opinion
Further Information Favourable Opinion