A Study to Determine Safety Tolerability Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers

  • STATUS
    Recruiting
  • End date
    Jan 25, 2024
  • participants needed
    112
  • sponsor
    AbbVie
Updated on 12 September 2021
cancer
hematologic malignancy
lung cancer
leukemia
primary cancer
solid tumor
lung carcinoma

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 determine recommended phase 2 dose (RP2D) and 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 participants will be enrolled in each arm. In dose expansion phase, around 20 participants will be enrolled in each arm. The study will be conducted in approximately 50 sites across 10 countries.

Participants will receive weight based intravenous (IV) infusion of ABBV-184 once a week. At the beginning of the study, visits will occur daily during hospitalization followed by less frequently over time.

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.

Details
Condition Non-Small Cell Lung Cancer, Cancer, Acute myeloid leukemia, Cancer/Tumors, Acute Myelogenous Leukemia (AML), Ewing's Family Tumors, Cancer (Pediatric), Neoplasms, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, nsclc, acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment ABBV-184
Clinical Study IdentifierNCT04272203
SponsorAbbVie
Last Modified on12 September 2021

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