First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies.
Recipient organisationNIHR University College London Hospitals Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Jul 2025
In plain English
AI plain-English summary
A new drug called ABBV-101 is being tested in roughly 188 patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma to see if it is safe and tolerable. Current treatments often fail—many patients see their cancer return or fail to improve—and new targeted options are urgently needed. Unlike existing BTK inhibitors that only block the BTK protein, ABBV-101 is a degrader that removes the protein entirely, potentially delivering a longer, more durable response by starving cancer cells of a key growth signal. If successful, this approach could shift the standard of care for B-cell malignancies, offering patients a once-daily oral tablet that keeps their disease in check for longer without the toxicity of chemotherapy. The study proceeds in two parts: dose escalation to find the safest dose, followed by dose expansion to test preliminary efficacy. This is an early-phase trial focused on safety and feasibility, not a cure—but it represents a concrete step toward a new class of cancer therapy that could improve outcomes for thousands of patients whose current options have run out.
View original technical description
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.
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