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
NCT ID: NCT07278336
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
207 participants
INTERVENTIONAL
2025-11-27
2029-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: ABBV-901 Dose Escalation
Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.
ABBV-901
Intravenous (IV)
Part 2: ABBV-901 Optimization/Expansion Dose A
Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.
ABBV-901
Intravenous (IV)
Part 2: ABBV-901 Optimization/Expansion Dose B
Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.
ABBV-901
Intravenous (IV)
Part 2: ABBV-901 Optimization/Expansion Dose C
Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.
ABBV-901
Intravenous (IV)
Part 3: ABBV-901 + Bevacizumab Escalation
Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
ABBV-901
Intravenous (IV)
Bevacizumab
IV
Part 4: ABBV-901 + Bevacizumab Expansion
Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
ABBV-901
Intravenous (IV)
Bevacizumab
IV
Interventions
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ABBV-901
Intravenous (IV)
Bevacizumab
IV
Eligibility Criteria
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Inclusion Criteria
* Participants must be considered platinum resistant. 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).
* Prior anticancer therapy:
* Must have received appropriate standard of care therapy and be appropriate for participation in a Phase I study in the opinion of the investigator.
* Platinum-resistant, high grade serous EOC cannot have had more than 5 prior lines of therapy, with clinical progression of disease on no more than 2 prior therapies since the development of platinum resistance.
* For participants enrolled in backfill, subjects must provide consent to paired biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.
Exclusion Criteria
* Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor.
* Prior history of Grade \>= 2 ILD or pneumonitis.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan.
* Must not have systemically used known strong cytochrome P450 (CYP)3A inhibitors or inducers within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the study drug through the end of the DLT observation period. If clinically indicated, strong CYP3A inhibitors and inducers may be used with caution after the dose-limiting toxicity (DLT) period.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
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
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama, Japan
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka, Japan
Countries
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Central Contacts
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Related Links
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Other Identifiers
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2025-522209-40
Identifier Type: OTHER
Identifier Source: secondary_id
M25-760
Identifier Type: -
Identifier Source: org_study_id
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