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

Carboplatin

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 other anticancer drugs, in participants with ovarian cancer.

ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 6 parts where participants will receive ABBV-901, alone or in combination with other anticancer therapies. Around 285 participants will be enrolled in the study at approximately 45 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 in combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV bevacizumab. in Part 5, participants will receive escalating doses of IV ABBV-901 in combination with IV carboplatin and IV bevacizumab and in part 6, participants will receive recommended doses for expansion of IV ABBV-901 combination with IV carboplatin and 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

Oct, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Dec, 2028

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 enrolled in backfill (Part 1) must provide consent to paired fresh biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.

For Parts 1-4:

\- 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).

For Parts 5-6:

\- Participants will have platinum-sensitive disease defined as radiographic progression > 6 months from last dose of platinum-based chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.

Exclusion Criteria:

  • Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, mucinous, carcinosarcoma or sarcomatous histology, mixed tumors or low grade/borderline ovarian tumor.
  • Participants with platinum refractory disease.
  • Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor.
  • Prior history of Grade >= 2 interstitial lung disease (ILD) or pneumonitis.
  • Prior history of Grade 2 >= 2 ILD or pneumonitis or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan.

For Parts 3-6:

  • History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab.
  • History of clinically significant cardiac disease including CHF Class II or higher NYHA; active coronary artery disease, MI within 6 months prior to study entry; unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted).
  • Echocardiogram with ejection fraction <= 50% and no other clinically significant cardiac abnormalities that in the opinion of the investigator, would increase the participants susceptibility to cardiac toxicity.

For Parts 5-6:

\- Participants who had prior allergic reaction to platinum containing compound.

Study Design

Enrollment

285 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 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 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 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.

experimental: Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation

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

experimental: Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion

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

Interventions

ABBV-901

Intravenous (IV)

Bevacizumab

Intravenous (IV)

Carboplatin

Intravenous (IV)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

City of Hope National Medical Center /ID# 281381

Recruiting

Duarte, California, United States, 91010

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914

Recruiting

Irvine, California, United States, 92618

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

University Of Nebraska Medical Center /ID# 281020

Recruiting

Omaha, Nebraska, United States, 68198

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

Oct 13, 2026

Last verified

Oct, 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 2026-10-23. This information was provided to ClinicalTrials.gov by AbbVie on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.