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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 Other Anticancer Drugs 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 other anticancer drugs, in participants with ovarian cancer. ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 6 parts where participants will receive ABBV-901, alone or in combination with other anticancer therapies. Around 285 participants will be enrolled in the study at approximately 45 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 in combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV bevacizumab. in Part 5, participants will receive escalating doses of IV ABBV-901 in combination with IV carboplatin and IV bevacizumab and in part 6, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV carboplatin and 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 in Adult Subjects With Ovarian Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
285
Start Date
2025-11-27
Completion Date
2029-01
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
ABBV-901
Intravenous (IV)
Bevacizumab
Intravenous (IV)
Carboplatin
Intravenous (IV)
Locations (27)
City of Hope National Medical Center /ID# 281381
Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914
Irvine, California, United States
Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado, United States
University of Chicago Medical Center /ID# 278295
Chicago, Illinois, United States
University Of Nebraska Medical Center /ID# 281020
Omaha, Nebraska, United States
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
Blacktown Hospital /ID# 282426
Blacktown, New South Wales, Australia
Monash Health - Monash Medical Centre - Clayton /ID# 281468
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre. /ID# 281751
Melbourne, Victoria, Australia
Institut De Cancerologie De L'Ouest - Site Rene Gauducheau /ID# 280684
Saint-Herblain, Pays de la Loire Region, France
Centre Leon Berard /ID# 280575
Lyon, Rhone, France
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
National Cancer Center Hospital East /ID# 278604
Kashiwa-shi, Chiba, Japan
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama, Japan
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka, Japan
Unidade Local de Saude de Santa Maria /ID# 280296
Lisbon, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 280293
Porto, Portugal
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 280459
Majadahonda, Madrid, Spain
Hospital Universitari Vall d Hebron /ID# 280442
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 280440
Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 280439
Madrid, Spain
National Taiwan University Hospital /ID# 280701
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 281349
Taipei, Taiwan