Ovarian CancerPhase 1NCT07278336
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 study testing ABBV-901, Bevacizumab and Carboplatin in people with Ovarian Cancer, run by AbbVie at 27 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- ABBV-901, Bevacizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 27 Nov 2025to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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:
Show all 11Show fewer
- 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.
Trial locations and contacts
27 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 8 countries
United States8 sites, 8 recruiting
- Recruiting
University of Chicago Medical Center /ID# 278295
Chicago, Illinois, 60637
- Recruiting
Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado, 80218
- Recruiting
City of Hope National Medical Center /ID# 281381
Duarte, California, 91010
- Recruiting
Next Virginia /ID# 278607
Fairfax, Virginia, 22031
- Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 280914
Irvine, California, 92618
- Recruiting
University Of Nebraska Medical Center /ID# 281020
Omaha, Nebraska, 68198
- Recruiting
NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas, 78229
- Recruiting
Start Mountain Region /ID# 278609
West Valley City, Utah, 84119
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitari Vall d Hebron /ID# 280442
Barcelona, 08035
- Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 280440
Madrid, 28040
- Recruiting
Hospital Universitario HM Sanchinarro /ID# 280439
Madrid, 28050
- Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 280459
Majadahonda, Madrid, 28222
Australia3 sites, 3 recruiting
- Recruiting
Blacktown Hospital /ID# 282426
Blacktown, New South Wales, 2148
- Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 281468
Clayton, Victoria, 3168
- Recruiting
Peter MacCallum Cancer Centre. /ID# 281751
Melbourne, Victoria, 3000
Israel3 sites, 3 recruiting
- Recruiting
Rambam Health Care Campus /ID# 278418
Haifa, 3109601
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 278420
Jerusalem, 91120
- Recruiting
The Chaim Sheba Medical Center /ID# 278416
Ramat Gan, Tel Aviv, 5265601
Japan3 sites, 3 recruiting
- Recruiting
Saitama Medical University International Medical Center /ID# 278437
Hidaka, Saitama, 350-1298
- Recruiting
National Cancer Center Hospital East /ID# 278604
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Shizuoka Cancer Center /ID# 278538
Sunto-gun, Shizuoka, 411-8777
France2 sites, 2 recruiting
- Recruiting
Centre Leon Berard /ID# 280575
Lyon, Rhone, 69373
- Recruiting
Institut De Cancerologie De L'Ouest - Site Rene Gauducheau /ID# 280684
Saint-Herblain, Pays de la Loire Region, 44805
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saude de Santa Maria /ID# 280296
Lisbon, 1649-035
- Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 280293
Porto, 4200-072
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital /ID# 280701
Taipei, 100
- Recruiting
Taipei Veterans General Hospital /ID# 281349
Taipei, 112
About this study
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
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.
Read more
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
- Being tested
- ABBV-901, Bevacizumab, Carboplatin
- Keywords
- Ovarian Cancer, Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers, ABBV-901, Bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-901Drug
Intravenous (IV)
BevacizumabDrug
Intravenous (IV)
CarboplatinDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-901 Dose Escalation | Experimental | Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901 |
| Part 2: ABBV-901 Optimization Dose A | Experimental | Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901 |
| Part 2: ABBV-901 Optimization Dose B | Experimental | Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901 |
| Part 2: ABBV-901 Optimization Dose C | Experimental | Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901 |
| Part 3: ABBV-901 + Bevacizumab Escalation | Experimental | Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901; Drug: Bevacizumab |
| Part 4: ABBV-901 + Bevacizumab Expansion | Experimental | Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901; Drug: Bevacizumab |
| Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation | Experimental | Participants will receive escalating doses of ABBV-901 in combination with Carboplatin \& Bevacizumab, as part of the approximately 3 year study duration. Receives: Drug: ABBV-901; Drug: Bevacizumab; Drug: Carboplatin |
| Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion | Experimental | 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. Receives: Drug: ABBV-901; Drug: Bevacizumab; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AE)
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.
Measured: Up to Approximately 3 Years
Overall Response (as assessed by the investigator)
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.
Measured: Up to Approximately 3 Years
Secondary outcomes (5)
Overall Response (as assessed by independent central review)
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).
Measured: Up to Approximately 3 Years
Duration of Response (DOR)
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.
Measured: Up to Approximately 3 Years
Progression-free survival (PFS)
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.
Measured: Up to Approximately 3 Years
Overall Survival (OS)
OS is defined as time from first study treatment to death due to any cause.
Measured: Up to Approximately 3 Years
Disease Control Rate
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.
Measured: Up to Approximately 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start27 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278336
- Sponsor's protocol ID
- M25-760
- Other IDs
- 2025-522209-40-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07278336
- Acronym / sponsor ID
- M25-760
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers, ABBV-901, Bevacizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-901 Dose Escalation | Experimental | Drug: ABBV-901Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration. |
| Part 2: ABBV-901 Optimization Dose A | Experimental | Drug: ABBV-901Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration. |
| Part 2: ABBV-901 Optimization Dose B | Experimental | Drug: ABBV-901Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration. |
| Part 2: ABBV-901 Optimization Dose C | Experimental | Drug: ABBV-901Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration. |
| Part 3: ABBV-901 + Bevacizumab Escalation | Experimental | Drug: ABBV-901, Drug: BevacizumabParticipants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration. |
| Part 4: ABBV-901 + Bevacizumab Expansion | Experimental | Drug: ABBV-901, Drug: BevacizumabParticipants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration. |
| Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation | Experimental | Drug: ABBV-901, Drug: Bevacizumab, Drug: CarboplatinParticipants will receive escalating doses of ABBV-901 in combination with Carboplatin \& Bevacizumab, as part of the approximately 3 year study duration. |
| Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion | Experimental | Drug: ABBV-901, Drug: Bevacizumab, Drug: CarboplatinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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).
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-901Intravenous (IV) | Drug | Part 1: ABBV-901 Dose Escalation, Part 2: ABBV-901 Optimization Dose A, Part 2: ABBV-901 Optimization Dose B, Part 2: ABBV-901 Optimization Dose C, Part 3: ABBV-901 + Bevacizumab Escalation, Part 4: ABBV-901 + Bevacizumab Expansion, Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation, Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion |
| BevacizumabIntravenous (IV) | Drug | Part 3: ABBV-901 + Bevacizumab Escalation, Part 4: ABBV-901 + Bevacizumab Expansion, Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation, Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion |
| CarboplatinIntravenous (IV) | Drug | Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation, Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion |
Primary outcome
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.
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.
5 secondary outcomes
Overall Response (as assessed by independent central review)
Time frame: Up to Approximately 3 Years
Duration of Response (DOR)
Time frame: Up to Approximately 3 Years
Progression-free survival (PFS)
Time frame: Up to Approximately 3 Years
Overall Survival (OS)
Time frame: Up to Approximately 3 Years
Disease Control Rate
Time frame: Up to Approximately 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-901, Bevacizumab and Carboplatin in people with Ovarian Cancer, run by AbbVie at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, Australia, Israel, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE) (time frame: Up to Approximately 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.