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
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
- Ovarian Cancer
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- AbbVie
- Enrolment target
- 285
- Started
- 27 November 2025
- Main results due
- December 2028
- Study sites
- 23
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Diagnosis of an advanced or unresectable malignant high grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC), fallopian tube or primary peritoneal cancer by histology (World Health Organization \[WHO\] criteria). * Participants enrolled in backfill (Part 1) must provide consent to paired fresh biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion. For Parts 1-4: \- Participants must be considered platinum resistant or platinum ineligible. Platinum resistant disease is defined as radiographic progression within 6 months (up to 182 days) after the last dose of the most recent platinum therapy). For Parts 5-6: \- Participants will have platinum-sensitive disease defined as radiographic progression \> 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Exclusion Criteria: * Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, mucinous, carcinosarcoma or sarcomatous histology, mixed tumors or low grade/borderline ovarian tumor. * Participants with platinum refractory disease. * Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor. * Prior history of Grade \>= 2 interstitial lung disease (ILD) or pneumonitis. * Prior history of Grade 2 \>= 2 ILD or pneumonitis or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan. For Parts 3-6: * History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab. * History of clinically significant cardiac disease including CHF Class II or higher NYHA; active coronary artery disease, MI within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted). * Echocardiogram with ejection fraction \<= 50% and no other clinically significant cardiac abnormalities that in the opinion of the investigator, would increase the participants susceptibility to cardiac toxicity. For Parts 5-6: \- Participants who had prior allergic reaction to platinum containing compound.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(23)
City of Hope National Medical Center /ID# 281381
Duarte, California, United States
Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914
Irvine, California, United States
Recruiting
Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado, United States
Recruiting
University of Chicago Medical Center /ID# 278295
Chicago, Illinois, United States
Recruiting
University Of Nebraska Medical Center /ID# 281020
Omaha, Nebraska, United States
Recruiting
NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas, United States
Recruiting
Start Mountain Region /ID# 278609
West Valley City, Utah, United States
Recruiting
Next Virginia /ID# 278607
Fairfax, Virginia, United States
Recruiting
Blacktown Hospital /ID# 282426
Blacktown, New South Wales, Australia
Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 281468
Clayton, Victoria, Australia
Recruiting
Peter MacCallum Cancer Centre. /ID# 281751
Melbourne, Victoria, Australia
Recruiting
The Chaim Sheba Medical Center /ID# 278416
Ramat Gan, Tel Aviv, Israel
Recruiting
Rambam Health Care Campus /ID# 278418
Haifa, Israel
Recruiting
Hadassah Medical Center-Hebrew University /ID# 278420
Jerusalem, Israel
Recruiting
National Cancer Center Hospital East /ID# 278604
Kashiwa-shi, Chiba, Japan
Recruiting
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama, Japan
Recruiting
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka, Japan
Recruiting
Unidade Local de Saude de Santa Maria /ID# 280296
Lisbon, Portugal
Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 280293
Porto, Portugal
Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 280459
Majadahonda, Madrid, Spain
Recruiting
Hospital Universitario HM Sanchinarro /ID# 280439
Madrid, Spain
Recruiting
National Taiwan University Hospital /ID# 280701
Taipei, Taiwan
Recruiting
Taipei Veterans General Hospital /ID# 281349
Taipei, Taiwan
Recruiting
Showing 23 of 23 sites. 23 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07278336. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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