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NCT07278336PHASE1Recruiting

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

AbbVie

Start Date

11/27/2025

Completion Date

1/1/2029

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 Criteria

Age Range: 18 years to No maximum

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 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). * 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 2 prior lines of therapy, since the development of platinum resistance or ineligibility. * 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: * Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor. * 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, or 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.

Interventions

DRUG

ABBV-901

DRUG

Bevacizumab

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Conditions

Ovarian Cancer

Locations

Sarah Cannon Research Institute at HealthONE /ID# 278785

Denver, Colorado 80218

United States

University of Chicago Medical Center /ID# 278295

Chicago, Illinois 60637

United States

NEXT Oncology - San Antonio /ID# 278606

San Antonio, Texas 78229

United States

Start Mountain Region /ID# 278609

West Valley City, Utah 84119

United States

Next Virginia /ID# 278607

Fairfax, Virginia 22031

United States

Sun Yat-Sen University Cancer Center /ID# 282505

Guangzhou, Guangdong 510060

China

Qilu Hospital Of Shandong University /ID# 283564

Jinan, Shandong 250014

China

Shandong Cancer Hospital /ID# 283566

Jinan, Shandong 250117

China

Fudan University Shanghai Cancer Center /ID# 282600

Shanghai, Shanghai Municipality 200032

China

The Chaim Sheba Medical Center /ID# 278416

Ramat Gan, Tel Aviv 5265601

Israel

Rambam Health Care Campus /ID# 278418

Haifa, 3109601

Israel

Hadassah Medical Center-Hebrew University /ID# 278420

Jerusalem, 91120

Israel

National Cancer Center Hospital East /ID# 278604

Kashiwa-shi, Chiba 277-8577

Japan

Saitama Medical University International Medical Center /ID# 278437

Hidaka, Saitama 350-1298

Japan

Shizuoka Cancer Center /ID# 278538

Sunto-gun, Shizuoka 411-8777

Japan

New Zealand Clinical Research (Christchurch) /ID# 281467

Christchurch, Canterbury 8011

New Zealand

Taipei Veterans General Hospital /ID# 281349

Taipei, 112

Taiwan