A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination With Bevacizumab in Adult Subjects With Ovarian Cancer
Summary
Ovarian cancer (OC) is a lethal disease. The purpose of this study is to assess the safety, pharmacokinetics and efficacy of ABBV901, alone or in combination with bevacizumab, in participants with ovarian cancer. ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 4 Parts (Arms) where participants will receive ABBV-901, alone or in combination with the standard available therapy, bevacizumab. Around 219 participants will be enrolled in the study at approximately 75 sites around the world. In part 1, participants will receive escalating doses of intravenous (IV) ABBV-901 alone. In part 2, participants will receive 1 of 3 doses of IV ABBV-901, alone to determine the optimized dose. In part 3, participants will receive escalating doses of IV ABBV-901, combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901, combination with IV bevacizumab. The total study duration will be approximately 3 years. There may be 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 and may require frequent medical assessments, blood tests, and scans.
Arms & interventions
- DrugABBV-901
Intravenous (IV)
- DrugBevacizumab
IV
Outcome measures
Primary
Number of Participants with Adverse Events (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 3 Years
Overall Response
Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.
Time frame: Up to Approximately 3 Years
Secondary
Duration of Response (DOR)
Time frame: Up to Approximately 3 Years
Progression-free survival (PFS)
Time frame: Up to Approximately 3 Years
Overall Survival (OS)
Time frame: Up to Approximately 3 Years
Disease Control Rate
Time frame: Up to Approximately 3 Years
Eligibility criteria
Study locations (5)
Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado, 80218
University of Chicago Medical Center /ID# 278295
Chicago, Illinois, 60637
NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas, 78229
Start Mountain Region /ID# 278609
West Valley City, Utah, 84119
Next Virginia /ID# 278607
Fairfax, Virginia, 22031