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NCT Number: NCT07278336

A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Blacktown Hospital /ID# 282426, Blacktown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-901

Drug

Intravenous (IV)

Bevacizumab

Drug

Intravenous (IV)

carboplatin

Drug

Intravenous (IV)

Primary outcomes

  1. Number of Participants with Adverse Events (AE)

    Time frame: 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.

  2. Overall Response (as assessed by the investigator)

    Time frame: 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.

Secondary outcomes

  1. Overall Response (as assessed by independent central review)

    Time frame: 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 independent central review (ICR).

  2. Duration of Response (DOR)

    Time frame: Up to Approximately 3 Years

    DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to RECIST Version 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.

  3. Progression-free survival (PFS)

    Time frame: Up to Approximately 3 Years

    PFS is defined as time from first study treatment to a documented disease progression according to RECIST Version 1.1 (or other assessment criteria), as determined by the investigator, or death due to any cause, whichever occurs earlier.

  4. Overall Survival (OS)

    Time frame: Up to Approximately 3 Years

    OS is defined as time from first study treatment to death due to any cause.

  5. Disease Control Rate

    Time frame: Up to Approximately 3 Years

    Disease Control Rate is defined as the percentage of participants with best overall response (BOR) of stable disease (SD), PR or better per investigator review according to RECIST version 1.1 criteria.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination in Adult Subjects With Ovarian Cancer

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Dec 12, 2025
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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