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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 Bevacizumab 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 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.

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 With Bevacizumab in Adult Subjects With Ovarian Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2025-11-27

Completion Date

2029-01

Last Updated

2026-01-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

ABBV-901

Intravenous (IV)

DRUG

Bevacizumab

IV

Locations (8)

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