A Phase 1 Study of ADCT-402 in Patients with Non-Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase 1 Dose-escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-402 in Patients with Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)
IRAS ID
213304
Contact name
Kirit Ardeshna
Contact email
Sponsor organisation
ADC Therapeutics SA
Eudract number
2016-000952-92
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
ADCT-402 is part of a class of medicines called antibody drug conjugates. It combines an antibody (a protein that identifies and makes harmful substances ineffective in the body) with chemotherapy (a drug medication that kills cancer cells). By combining the antibody with the chemotherapy, antibody drug conjugates are designed to selectively target and kill cancer cells.
Non-Hodgkin lymphoma (NHL) is an uncommon cancer that develops in the lymphatic system, which is a network of vessels and glands spread throughout the body. The lymphatic system is part of the immune system. This study is the first testing of ADCT-402 in humans. The first part of this study is to assess the safety of ADCT-402, and find the highest dose level that can be safely taken by participants. The second part of the study is designed to determine if the highest safe dose may be effective in treating NHL. Up to about 60 participants will take part in this study at approximately 20 study sites.
For each participant, the study includes a Screening Period (up to 28 days), a Treatment Period, and a Follow-Up Period for up to 12 months after the last dose of ADCT-402. During the Treatment Period, ADCT-402 will be given as an infusion (directly into a vein) every 3 weeks. The total duration of the Treatment Period will depend on how well ADCT-402 is tolerated. The participant will remain on the study for as long as there is a response to the treatment.
The dose of ADCT-402 the participants receive will depend on when they enroll into the study. The lowest dose will be 15 micrograms (mcg) for each kilogram of body weight, and the highest dose will be 300 mcg for each kilogram of a body weight. Once the study stops care will continue under management of the treating doctor according to standard of care.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0342
Date of REC Opinion
20 Jan 2017
REC opinion
Further Information Favourable Opinion