M19-747: ABBV-184 in Subjects with Previously Treated AML and NSCLC
Research type
Research Study
Full title
A Phase 1 First in Human, Multicenter, Open-Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and RP2D of ABBV-184 in Subjects with Previously Treated Cancers
IRAS ID
274952
Contact name
Natalia Tomkiewicz
Contact email
Sponsor organisation
AbbVie UK
Eudract number
2019-003434-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 2 days
Research summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. This study focuses on two types of cancers: Acute Myeloid Leukemia (AML) and Non-Small Cell Lung Cancer (NSCLC). AML (blood cancer) is cancer of the White Blood Cells (WBC). NSCLC (solid tumor) is a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to see if the study drug is safe and able to treat patients who have AML and NSCLC.
ABBV-184 is an investigational drug being developed for treatment of cancer. The study has two arms and two phases: AML arm and NSCLC arm; dose escalation and dose expansion phase. Adult participants with diagnosis of AML or NSCLC will be enrolled. In dose escalation phase, around 36 subjects will be enrolled in each arm. In dose expansion phase, a total of 48 subjects will be enrolled. The study will be conducted in approximately 50 sites across 10 countries.
Participants will receive weight based intravenous (IV) ABBV-184 once a week every 3 weeks, in a clinic. Visits will occur approximately 1-2 times per week, but it may be required to come more frequently for blood tests and other exams to see how well the cancer is responding to treatment.There will be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood tests, checking for side effects, and questionnaires.
REC name
HSC REC A
REC reference
20/NI/0102
Date of REC Opinion
16 Sep 2020
REC opinion
Further Information Favourable Opinion