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

NCT07278336 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: M25-7602025-522209-40-00
• Study Type: interventional
• Target: 219
• Locations: 6 countries
• Sites: 17

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 bevacizumab, in participants with ovarian cancer. ABBV901 is an investigational drug for the treatment of ovarian cancer. This study has 4 Parts (Arms) where participants will receive ABBV-901, alone or in combination with the standard available therapy, bevacizumab. Around 219 participants will be enrolled in the study at approximately 75 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, combination with IV bevacizumab. In part 4, participants will receive recommended doses for expansion of IV ABBV-901, combination with 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

  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 (4)

• 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 (6)

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/Expansion 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/Expansion 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/Expansion 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

Interventions

ABBV-901 DRUG

Intravenous (IV)

Part 1: ABBV-901 Dose Escalation; Part 2: ABBV-901 Optimization/Expansion Dose A; Part 2: ABBV-901 Optimization/Expansion Dose B; Part 2: ABBV-901 Optimization/Expansion Dose C; Part 3: ABBV-901 + Bevacizumab Escalation; Part 4: ABBV-901 + Bevacizumab Expansion

Bevacizumab DRUG

IV

Part 3: ABBV-901 + Bevacizumab Escalation; Part 4: ABBV-901 + 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 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).
• Prior anticancer therapy:
• Must have received appropriate standard of care therapy and be appropriate for participation in a Phase I study in the opinion of the investigator.
• Platinum-resistant, high grade serous EOC cannot have had more than 2 prior lines of therapy, since the development of platinum resistance or ineligibility.
• For participants enrolled in backfill, subjects must provide consent to paired biopsies which are pretreatment and on-treatment tumor biopsies from the same tumor lesion.

You may not qualify if:

• Ovarian Cancer (OC) with histologies other than high grade serous OC including endometrioid, low grade, clear cell, mucinous, or borderline ovarian tumor.
• Prior therapy with an antibody-drug conjugate containing a topoisomerase inhibitor.
• Prior history of Grade \>= 2 ILD or pneumonitis.
• History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on Screening chest computed tomography (CT) scan.
• Must not have systemically used known strong cytochrome P450 (CYP)3A inhibitors or inducers within 14 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the study drug through the end of the DLT observation period. If clinically indicated, strong CYP3A inhibitors and inducers may be used with caution after the dose-limiting toxicity (DLT) period.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (17)

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

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

Sun Yat-Sen University Cancer Center /ID# 282505

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Qilu Hospital Of Shandong University /ID# 283564

Jinan, Shandong, 250014, China

NOT YET RECRUITING

Shandong Cancer Hospital /ID# 283566

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center /ID# 282600

Shanghai, Shanghai Municipality, 200032, China

NOT YET 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

New Zealand Clinical Research (Christchurch) /ID# 281467

Christchurch, Canterbury, 8011, New Zealand

NOT YET RECRUITING

Taipei Veterans General Hospital /ID# 281349

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

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

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): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); US (5); IL (3); CN (4); JP (3); TW (1)