First-in-Human Study to Evaluate the Safety of ABBV-101, inParticipants with B-cells Malignancies
Research type
Research Study
Full title
First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies.
IRAS ID
1008642
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2023-503594-38
ISRCTN Number
Not available
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1, first-in-human, open-label study of ABBV-101. The purpose of this study is to determine if ABBV-101 is safe and tolerable in patients with relapsed or refractory (R/R) B-cell non-Hodgkin's lymphoma (NHL).
ABBV-101 belongs to a group of drugs called BTK (Bruton’s tyrosine kinase) degraders. Non-Hodgkin’s lymphoma (NHL) arises from the formation of abnormal B and T cells (lymphocytes). The BTK protein is a key component that helps normal B cells grow. It has also been shown to help cancer cells live and grow. A degrader is a drug that has the ability to remove proteins, in this case BTK. By removing the BTK ABBV-101 may reduce growth and survival of the abnormal B cells in NHL and may provide a longer, more durable response than current BTK inhibitor treatments.
Treatments are available for patients with B-cell malignancies, but many patients with B-cell malignancies have their cancer come back or not get better with treatment. New targeted treatments are needed.
The study will include approximately 188 patients aged 18 or older with relapsed or refractory B-cell non-Hodgkin's lymphoma.ABBV-101 but will be given once a day by mouth (tablet format) for approximately 60 months, until disease gets worse, until patients are unable to tolerate study treatment, or until the patient or study doctor choose to stop participation in the study for any reason.
The current study plan will have 2 parts:
• Part 1: Dose Escalation – Patients will be placed into the available dose level group for ABBV-101 depending on when they join the study. They will be monitored for side effects and higher dose level groups will not enrol patients until safety information from the lower groups are evaluated. At the end of Part 1, safety information will be reviewed for all patients treated in Part 1 and an ABBV-101 dose to be used in Part 2 will be determined
• Part 2: Dose Expansion – Patients will receive ABBV-101 at the dose level determined in Part 1.REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0338
Date of REC Opinion
11 Dec 2023
REC opinion
Further Information Favourable Opinion