Tests ABBV-901 alone or with other drugs in adults with ovarian cancer
Tests the investigational drug ABBV-901, alone or combined, in adults with ovarian cancer.
Key facts
- Who runs it
- AbbVie
- Where
- Lisbon and Porto, PortugalSee the 2 sitesAlso in 8 other countries, 27 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 285 people, planned
- Started
- 27 Nov 2025
- Expected to end
- Jan 2029
- Type of study
- Interventional, 8 groups
- Treatments tested
- ABBV-901
- Bevacizumab
- Carboplatin
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or unresectable high grade serous ovarian, fallopian tube or primary peritoneal cancer. They would receive ABBV-901 alone or with other cancer drugs.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or unresectable high grade serous ovarian, fallopian tube or primary peritoneal cancer. In Parts 1-4 the cancer must be platinum resistant or platinum ineligible. In Parts 5-6 it must be platinum sensitive.
- Earlier treatment
- Parts 1-4: cancer that progressed on scans within 6 months (up to 182 days) after the last platinum therapy, or platinum ineligible. Parts 5-6: cancer that progressed more than 6 months after the last platinum chemotherapy. No earlier antibody-drug conjugate that contains a topoisomerase inhibitor.
Main reasons for not taking part
- Ovarian cancer types other than high grade serous
- Platinum refractory disease
- Earlier antibody-drug conjugate with a topoisomerase inhibitor
- History of Grade 2 or higher interstitial lung disease or pneumonitis, or active lung inflammation on the screening scan
- Parts 3-6: serious heart disease, or ejection fraction of 50% or lower on echocardiogram
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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)
- Participants who had prior allergic reaction to platinum containing compound
- 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
- History of Grade 3/4 adverse events that, in the opinion of the investigator, are attributed to bevacizumab
- 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:
Where in Portugal
Also in 8 other countries, 27 sites
- Unidade Local De Saude De Santa Maria E.P.E.Lisbon, PortugalTaking people
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.Porto, PortugalTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 8 groups in the trial
- Part 1: ABBV-901 Dose EscalationTreatment being tested
Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.
Treatment: ABBV-901
- Part 2: ABBV-901 Optimization Dose ATreatment being tested
Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.
Treatment: ABBV-901
- Part 2: ABBV-901 Optimization Dose BTreatment being tested
Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.
Treatment: ABBV-901
- Part 2: ABBV-901 Optimization Dose CTreatment being tested
Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.
Treatment: ABBV-901
- Part 3: ABBV-901 + Bevacizumab EscalationTreatment being tested
Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
Treatment: ABBV-901 and Bevacizumab
- Part 4: ABBV-901 + Bevacizumab ExpansionTreatment being tested
Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
Treatment: ABBV-901 and Bevacizumab
- Part 5: ABBV-901 + Carboplatin + Bevacizumab EscalationTreatment being tested
Participants will receive escalating doses of ABBV-901 in combination with Carboplatin \& Bevacizumab, as part of the approximately 3 year study duration.
Treatment: ABBV-901, Bevacizumab, and Carboplatin
- Part 6: ABBV-901 + Carboplatin + Bevacizumab ExpansionTreatment being tested
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.
Treatment: ABBV-901, Bevacizumab, and Carboplatin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- Tests ABBV-901 alone or with other drugs in adults with ovarian cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 October 2026