A Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Cancer

Overview

This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety, tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.

SparkCures ID 879
Trial Phase Phase 1
Enrollment 150 Patients
Treatments
Trial Sponsors
  • AbbVie
NCT Identifier

NCT02391480

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  1. Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.
  2. Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
  3. Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)
  4. Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.
  5. Adequate bone marrow, renal, and hepatic function.
  6. QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.

Exclusion Criteria:

  1. Participant has untreated brain or meningeal metastases.
  2. Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day 1.
  3. Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
  4. Symptoms of gross hematuria or gross hemoptysis.
  5. Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).
  6. History of long QT syndrome.
  7. Peripheral neuropathy great than or equal to grade 2.

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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