PROTOCOL ADCT-601-102
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 Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with Selected Advanced Solid Tumors
IRAS ID
1005850
Contact name
Viet-Anh Do
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2021-005566-18
Clinicaltrials.gov Identifier
Research summary
The aim of the study to find a safe and tolerable dose of a new experimental treatment called mipasetamab uzoptirine (ADCT-601), and to learn whether this treatment will be an effective treatment option for patients with selected advanced solid tumours. This study drug is an antibody-drug conjugate, meaning it is an antibody bound to an anti-cancer drug. In preclinical animal studies, data showed strong anti-tumour activity of ADCT-601 with gemcitabine. In a previous clinical study, ADCT-601 was found to be safe and generally well tolerated. This study is an open-label, phase 1b study that comprise of two parts namely, a dose escalation part and a dose expansion part. Both parts of the study will involve two arms and participants may receive either monotherapy (on its own) or combination therapy. 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. The second group of 3 patients receive a higher dose. Each new dose is thereafter increased after at least 3 patients have been dosed with no side effects. This dose escalation continues until a dose is identified as the dose to be used in the expansion part. ADCT-601 will be given as an intravenous (IV) infusion over 30 minutes on Day 1 of each cycle. Gemcitabine will be given as an IV infusion over 30 min on Day1 and Day 8 for 6 cycles. The response to the treatment will be assessed by radiographic tumour assessments and tumour markers. 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) CT/MRI/PET/Bone scans (f) tumour tissue collection (g) IV Infusion of study drugs
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0235
Date of REC Opinion
19 Jan 2023
REC opinion
Further Information Favourable Opinion