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RECRUITING
NCT07278336
PHASE1

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2025-11-27

Completion Date

2029-01

Last Updated

2026-10-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

ABBV-901

Intravenous (IV)

DRUG

Bevacizumab

Intravenous (IV)

DRUG

Carboplatin

Intravenous (IV)

Locations (27)

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