RecruitingPhase 1NCT07278336

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

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


Sponsor

AbbVie

Enrollment

219 participants

Start Date

Nov 27, 2025

Study Type

INTERVENTIONAL

Conditions

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 219 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called ABBV901 — alone or with bevacizumab — for women with advanced ovarian, fallopian tube, or peritoneal cancer that has stopped responding to platinum-based chemotherapy. **You may be eligible if...** - You have high-grade serous ovarian, fallopian tube, or peritoneal cancer confirmed by biopsy - Your cancer progressed within 6 months of your last platinum chemotherapy (platinum-resistant) - You have received standard treatments before and have had no more than 5 prior treatment lines - You are willing to provide tumor biopsy samples **You may NOT be eligible if...** - Your ovarian cancer is a non-serous type (e.g., clear cell, endometrioid, mucinous, or borderline) - You have previously received an antibody-drug conjugate containing a topoisomerase inhibitor - You have a history of significant lung inflammation (ILD or pneumonitis requiring steroids) - You are on certain medications that interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-901

Intravenous (IV)

DRUGBevacizumab

IV


Locations(16)

Sarah Cannon Research Institute at HealthONE /ID# 278785

Denver, Colorado, United States

University of Chicago Medical Center /ID# 278295

Chicago, Illinois, 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

Sun Yat-Sen University Cancer Center /ID# 282505

Guangzhou, Guangdong, China

Qilu Hospital Of Shandong University /ID# 283564

Jinan, Shandong, China

Shandong Cancer Hospital /ID# 283566

Jinan, Shandong, China

Fudan University Cancer Hospital /ID# 282600

Shanghai, Shanghai Municipality, China

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

New Zealand Clinical Research (Christchurch) /ID# 281467

Christchurch, Canterbury, New Zealand

View Full Details on ClinicalTrials.gov

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NCT07278336


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