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

NCT07278336 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: M25-7602025-522209-40-002025
• Study Type: interventional
• Target: 285
• Locations: 7 countries
• Sites: 24

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

Keywords

Ovarian Cancer; Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers; ABBV-901; Bevacizumab

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to Approximately 3 Years

Secondary Outcomes (5)

• Overall Response (as assessed by independent central review)

  Up to Approximately 3 Years

• Duration of Response (DOR)

  Up to Approximately 3 Years

• Progression-free survival (PFS)

  Up to Approximately 3 Years

• Overall Survival (OS)

  Up to Approximately 3 Years

• Disease Control Rate

  Up to Approximately 3 Years

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Drug: ABBV-901; Drug: Bevacizumab; Drug: Carboplatin

Interventions

ABBV-901 DRUG

Intravenous (IV)

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

Bevacizumab DRUG

Intravenous (IV)

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

Carboplatin DRUG

Intravenous (IV)

Part 5: ABBV-901 + Carboplatin + Bevacizumab Escalation; Part 6: ABBV-901 + Carboplatin + Bevacizumab Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (24)

City of Hope National Medical Center /ID# 281381

Duarte, California, 91010, United States

RECRUITING

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

Irvine, California, 92618, United States

RECRUITING

Sarah Cannon Research Institute at HealthONE /ID# 278785

Denver, Colorado, 80218, United States

RECRUITING

University of Chicago Medical Center /ID# 278295

Chicago, Illinois, 60637, United States

RECRUITING

University Of Nebraska Medical Center /ID# 281020

Omaha, Nebraska, 68198, United States

RECRUITING

NEXT Oncology - San Antonio /ID# 278606

San Antonio, Texas, 78229, United States

RECRUITING

Start Mountain Region /ID# 278609

West Valley City, Utah, 84119, United States

RECRUITING

Next Virginia /ID# 278607

Fairfax, Virginia, 22031, United States

RECRUITING

Blacktown Hospital /ID# 282426

Blacktown, New South Wales, 2148, Australia

RECRUITING

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

Clayton, Victoria, 3168, Australia

RECRUITING

Peter MacCallum Cancer Centre. /ID# 281751

Melbourne, Victoria, 3000, Australia

RECRUITING

The Chaim Sheba Medical Center /ID# 278416

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Rambam Health Care Campus /ID# 278418

Haifa, 3109601, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 278420

Jerusalem, 91120, Israel

RECRUITING

National Cancer Center Hospital East /ID# 278604

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

Saitama Medical University International Medical Center /ID# 278437

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Shizuoka Cancer Center /ID# 278538

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

Unidade Local de Saude de Santa Maria /ID# 280296

Lisbon, 1649-035, Portugal

RECRUITING

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

Porto, 4200-072, Portugal

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 280459

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz /ID# 280440

Madrid, 28040, Spain

RECRUITING

Hospital Universitario HM Sanchinarro /ID# 280439

Madrid, 28050, Spain

RECRUITING

National Taiwan University Hospital /ID# 280701

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital /ID# 281349

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 12, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); IL (3); JP (3); TW (2); PT (2); AU (3); ES (3)