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 (NCT07278336)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Sarah Cannon Research Institute at HealthONE /ID# 278785 โ Denver, Colorado
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (17 Sites)
- Sarah Cannon Research Institute at HealthONE /ID# 278785 โ Denver, Colorado
- University of Chicago Medical Center /ID# 278295 โ Chicago, Illinois
- NEXT Oncology - San Antonio /ID# 278606 โ San Antonio, Texas
- Start Mountain Region /ID# 278609 โ West Valley City, Utah
- Next Virginia /ID# 278607 โ Fairfax, Virginia
- Sun Yat-Sen University Cancer Center /ID# 282505 โ Guangzhou, Guangdong
- Qilu Hospital Of Shandong University /ID# 283564 โ Jinan, Shandong
- Shandong Cancer Hospital /ID# 283566 โ Jinan, Shandong
- Fudan University Shanghai Cancer Center /ID# 282600 โ Shanghai, Shanghai Municipality
- The Chaim Sheba Medical Center /ID# 278416 โ Ramat Gan, Tel Aviv
- Rambam Health Care Campus /ID# 278418 โ Haifa,
- Hadassah Medical Center-Hebrew University /ID# 278420 โ Jerusalem,
- National Cancer Center Hospital East /ID# 278604 โ Kashiwa-shi, Chiba
- Saitama Medical University International Medical Center /ID# 278437 โ Hidaka, Saitama
- Shizuoka Cancer Center /ID# 278538 โ Sunto-gun, Shizuoka
- New Zealand Clinical Research (Christchurch) /ID# 281467 โ Christchurch, Canterbury
- Taipei Veterans General Hospital /ID# 281349 โ Taipei,
๐ Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ovarian Cancer
- Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy โ New York, New York
- Safety and Efficacy of Anti-CD47, ALX148 in Combination With Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer โ Pittsburgh, Pennsylvania
- Trial on Radical Upfront Surgery in Advanced Ovarian Cancer โ New York, New York
- Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) โ Duarte, California
- Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302) โ Little Rock, Arkansas
- NeoVax With Nivolumab in Patients With Ovarian Cancer โ Boston, Massachusetts
Explore by condition: All Ovarian Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.