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
Start Date
11/27/2025
Completion Date
1/1/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABBV-901
Bevacizumab
Conditions
Locations
Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado 80218
United States
University of Chicago Medical Center /ID# 278295
Chicago, Illinois 60637
United States
NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas 78229
United States
Start Mountain Region /ID# 278609
West Valley City, Utah 84119
United States
Next Virginia /ID# 278607
Fairfax, Virginia 22031
United States
Sun Yat-Sen University Cancer Center /ID# 282505
Guangzhou, Guangdong 510060
China
Qilu Hospital Of Shandong University /ID# 283564
Jinan, Shandong 250014
China
Shandong Cancer Hospital /ID# 283566
Jinan, Shandong 250117
China
Fudan University Shanghai Cancer Center /ID# 282600
Shanghai, Shanghai Municipality 200032
China
The Chaim Sheba Medical Center /ID# 278416
Ramat Gan, Tel Aviv 5265601
Israel
Rambam Health Care Campus /ID# 278418
Haifa, 3109601
Israel
Hadassah Medical Center-Hebrew University /ID# 278420
Jerusalem, 91120
Israel
National Cancer Center Hospital East /ID# 278604
Kashiwa-shi, Chiba 277-8577
Japan
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama 350-1298
Japan
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka 411-8777
Japan
New Zealand Clinical Research (Christchurch) /ID# 281467
Christchurch, Canterbury 8011
New Zealand
Taipei Veterans General Hospital /ID# 281349
Taipei, 112
Taiwan