Actively Recruiting
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
Led by AbbVie · Updated on 2026-01-20
207
Participants Needed
8
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of advanced or unresectable high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer by histology
- Must be considered platinum resistant with disease progression within 6 months after last platinum therapy
- Must have received appropriate standard of care therapy and be suitable for Phase I study participation
- No more than 5 prior lines of therapy for platinum-resistant high grade serous epithelial ovarian cancer
- Clinical progression on no more than 2 prior therapies since development of platinum resistance
- For backfill participants, must consent to paired tumor biopsies from the same lesion pre- and on-treatment
You will not qualify if you...
- Ovarian cancer types other than high grade serous, including endometrioid, low grade, clear cell, mucinous, or borderline tumors
- Prior therapy with antibody-drug conjugate containing topoisomerase inhibitor
- History of Grade 2 or higher interstitial lung disease or pneumonitis
- Active interstitial lung disease or pneumonitis at screening
- Recent systemic use of strong cytochrome P450 3A inhibitors or inducers within 14 days or 5 half-lives before first study drug dose until end of dose-limiting toxicity period unless clinically indicated
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Trial Site Locations
Total: 8 locations
1
NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas, United States, 78229
Actively Recruiting
2
Start Mountain Region /ID# 278609
West Valley City, Utah, United States, 84119
Actively Recruiting
3
Next Virginia /ID# 278607
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
The Chaim Sheba Medical Center /ID# 278416
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
5
Rambam Health Care Campus /ID# 278418
Haifa, Israel, 3109601
Actively Recruiting
6
Hadassah Medical Center-Hebrew University /ID# 278420
Jerusalem, Israel, 91120
Actively Recruiting
7
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama, Japan, 350-1298
Actively Recruiting
8
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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