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

NCT07278336 · tracked via the Priya Life Science China tracker

Sponsor

AbbVie

Phase

Phase 1

Started

2025-11-27

Last updated

2026-07-15

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

ABBV-901Bevacizumab

ABBV-901: Intravenous (IV)

Bevacizumab: IV

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants with Adverse Events (AE) — Up to Approximately 3 Years
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.
Overall Response — Up to Approximately 3 Years
Overall response is defined as participants achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.

Trial sites (17)

Facility	City	Region	Status
Sarah Cannon Research Institute at HealthONE /ID# 278785	Denver	Colorado	Recruiting
University of Chicago Medical Center /ID# 278295	Chicago	Illinois	Recruiting
NEXT Oncology - San Antonio /ID# 278606	San Antonio	Texas	Recruiting
Start Mountain Region /ID# 278609	West Valley City	Utah	Recruiting
Next Virginia /ID# 278607	Fairfax	Virginia	Recruiting
Sun Yat-Sen University Cancer Center /ID# 282505	Guangzhou	Guangdong	Not Yet Recruiting
Qilu Hospital Of Shandong University /ID# 283564	Jinan	Shandong	Not Yet Recruiting
Shandong Cancer Hospital /ID# 283566	Jinan	Shandong	Not Yet Recruiting
Fudan University Shanghai Cancer Center /ID# 282600	Shanghai	Shanghai Municipality	Not Yet Recruiting
The Chaim Sheba Medical Center /ID# 278416	Ramat Gan	Tel Aviv	Recruiting
Rambam Health Care Campus /ID# 278418	Haifa	Israel	Recruiting
Hadassah Medical Center-Hebrew University /ID# 278420	Jerusalem	Israel	Recruiting
National Cancer Center Hospital East /ID# 278604	Kashiwa-shi	Chiba	Recruiting
Saitama Medical University International Medical Center /ID# 278437	Hidaka	Saitama	Recruiting
Shizuoka Cancer Center /ID# 278538	Sunto-gun	Shizuoka	Recruiting
New Zealand Clinical Research (Christchurch) /ID# 281467	Christchurch	Canterbury	Not Yet Recruiting
Taipei Veterans General Hospital /ID# 281349	Taipei	Taiwan	Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07278336 on ClinicalTrials.gov ↗ ← All trials in China