Efficacy and Safety of ADCT-301 in Relapsed or Refractory HL
Research type
Research Study
Full title
A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma
IRAS ID
253964
Contact name
Graham Collins
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2018-002556-32
Clinicaltrials.gov Identifier
121912, IND
Duration of Study in the UK
3 years, 11 months, 12 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 cases.
Camidanlumab tesirine (“Cami”; company code: ADCT-301) is an antibody drug conjugate (a medication with a drug being 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 and other lymphocytes surrounding the tumour cells. PBD dimers are highly efficient anticancer drugs and targeting lymphocytes surrounding the cancer cells may produce additional tumour cell killing.
The purpose of this Phase 2 study is to evaluate the effectiveness and safety of camidanlumab tesirine in participants with HL that has gotten worse or come back after treatment.
Approximately 100 participants will take part in this study. For each participant, the study includes a Screening Period (up to 28 days), a Treatment Period (cycles of 3 weeks), and a Follow-Up Period (approximately every 12 weeks visits for up to 3 years after the last dose of Cami). 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.
The duration of the study participation for each participant is defined as the time from the date of signed written informed consent to the completion of the follow-up period, withdrawal of consent, loss to follow-up, or death,
whichever occurs first.REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/1408
Date of REC Opinion
29 Oct 2019
REC opinion
Favourable Opinion