Recruiting
Phase 1

ABBV-901 & Bevacizumab

Sponsor:

AbbVie

Code:

NCT07278336

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-901

Bevacizumab

Study Details

Brief 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.

Conditions

Ovarian Cancer

Study ID

NCT07278336

Start date

Nov 27, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

219 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: ABBV-901 Dose Escalation

Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.

experimental: Part 2: ABBV-901 Optimization/Expansion Dose A

Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.

experimental: Part 2: ABBV-901 Optimization/Expansion Dose B

Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.

experimental: Part 2: ABBV-901 Optimization/Expansion Dose C

Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.

experimental: Part 3: ABBV-901 + Bevacizumab Escalation

Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.

experimental: Part 4: ABBV-901 + Bevacizumab Expansion

Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.

Interventions

ABBV-901

Intravenous (IV)

Bevacizumab

IV

Primary outcome measure

  • Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 3 Years ]
  • Overall Response [ Time Frame: Up to Approximately 3 Years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Sarah Cannon Research Institute at HealthONE /ID# 278785

Recruiting

Denver, Colorado, United States, 80218

University of Chicago Medical Center /ID# 278295

Recruiting

Chicago, Illinois, United States, 60637

NEXT Oncology - San Antonio /ID# 278606

Recruiting

San Antonio, Texas, United States, 78229

Start Mountain Region /ID# 278609

Recruiting

West Valley City, Utah, United States, 84119

Next Virginia /ID# 278607

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AbbVie

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Ovarian Cancer
  • Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
  • ABBV-901
  • Bevacizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-15.