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A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Bevacizumab in Adult Participants With Ovarian Cancer
Sponsor: AbbVie
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 207 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
207
Start Date
2025-11-27
Completion Date
2029-01
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
ABBV-901
Intravenous (IV)
Bevacizumab
IV
Locations (8)
NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas, United States
Start Mountain Region /ID# 278609
West Valley City, Utah, United States
Next Virginia /ID# 278607
Fairfax, Virginia, United States
The Chaim Sheba Medical Center /ID# 278416
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 278418
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 278420
Jerusalem, Israel
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama, Japan
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka, Japan