Phase 1 study of ADCT-301 in Lymphoma patients
Research type
Research Study
Full title
A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin
IRAS ID
199948
Contact name
Paul Fields
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2015-005272-25
Duration of Study in the UK
2 years, 0 months, 27 days
Research summary
Lymphoma is a group of blood cell tumours that develop from lymphatic cells. Lymphoma cells have been shown to express a protein on their surface called CD25 in approximately 58% to 78% of Hodgkin lymphoma, 42% to 50% of peripheral T-cell lymphoma, 54% of cutaneous T-cell lymphoma, and 40% of diffuse large B-cell lymphoma cases.
ADCT-301 is an antibody drug conjugate (a medication that is attached to an antibody). The antibody (HuMax®-TAC) targets the protein CD25 in the body, meaning that the attached drug (a pyrrolobenzodiazepine (PBD) dimer cytotoxin) is targeted to the cells that express the CD25 on their surface, i.e. lymphoma cells. PBD dimers are highly efficient anticancer drugs.
The potential for ADCT-301 in treating haematological malignancies which demonstrate CD25 over-expression has been shown by complete responses in mouse xenograft models (human tumour grafts in mice). The effectiveness of ADCT-301 in these models is due to targeted delivery of the PBD. The safety of ADCT-301 has been assessed in nonclinical testing.
This is a Phase 1, first-in-human (FIH), open-label study of ADCT-301 in patients with relapsed and refractory lymphoma that will be conducted in 2 parts. Part 1 (dose-escalation) will determine the maximum tolerated dose (MTD) (i.e. 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 of ADCT-301 is in participants.
This study will include 90 participants (60 in Part 1 and 30 in Part 2) at sites in the USA and the UK. 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
North West - Haydock Research Ethics Committee
REC reference
16/NW/0272
Date of REC Opinion
19 May 2016
REC opinion
Further Information Favourable Opinion