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NCT07278336From ClinicalTrials.govRecruiting

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

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

  • Ovarian Cancer

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
AbbVie
Enrolment target
285
Started
27 November 2025
Main results due
December 2028
Study sites
23
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(23)

  • City of Hope National Medical Center /ID# 281381

    Duarte, California, United States

    Recruiting

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

    Irvine, California, United States

    Recruiting

  • Sarah Cannon Research Institute at HealthONE /ID# 278785

    Denver, Colorado, United States

    Recruiting

  • University of Chicago Medical Center /ID# 278295

    Chicago, Illinois, United States

    Recruiting

  • University Of Nebraska Medical Center /ID# 281020

    Omaha, Nebraska, United States

    Recruiting

  • NEXT Oncology - San Antonio /ID# 278606

    San Antonio, Texas, United States

    Recruiting

  • Start Mountain Region /ID# 278609

    West Valley City, Utah, United States

    Recruiting

  • Next Virginia /ID# 278607

    Fairfax, Virginia, United States

    Recruiting

  • Blacktown Hospital /ID# 282426

    Blacktown, New South Wales, Australia

    Recruiting

  • Monash Health - Monash Medical Centre - Clayton /ID# 281468

    Clayton, Victoria, Australia

    Recruiting

  • Peter MacCallum Cancer Centre. /ID# 281751

    Melbourne, Victoria, Australia

    Recruiting

  • The Chaim Sheba Medical Center /ID# 278416

    Ramat Gan, Tel Aviv, Israel

    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, Japan

    Recruiting

  • Saitama Medical University International Medical Center /ID# 278437

    Hidaka, Saitama, Japan

    Recruiting

  • Shizuoka Cancer Center /ID# 278538

    Sunto-gun, Shizuoka, Japan

    Recruiting

  • Unidade Local de Saude de Santa Maria /ID# 280296

    Lisbon, Portugal

    Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 280293

    Porto, Portugal

    Recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 280459

    Majadahonda, Madrid, Spain

    Recruiting

  • Hospital Universitario HM Sanchinarro /ID# 280439

    Madrid, Spain

    Recruiting

  • National Taiwan University Hospital /ID# 280701

    Taipei, Taiwan

    Recruiting

  • Taipei Veterans General Hospital /ID# 281349

    Taipei, Taiwan

    Recruiting

Showing 23 of 23 sites. 23 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07278336. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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