RECRUITING Phase 1 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07278336

Registry updated: 2026-10-13

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Description

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.

Interventions

ABBV-901 (Drug)
Intravenous (IV)
Bevacizumab (Drug)
Intravenous (IV)
Carboplatin (Drug)
Intravenous (IV)

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.

Conditions

Ovarian Cancer

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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