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

Purpose

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.

Condition

  • Ovarian Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: ABBV-901 Dose Escalation 		Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.
  • Drug: ABBV-901
    Intravenous (IV)
Experimental
Part 2: ABBV-901 Optimization/Expansion Dose A 		Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.
  • Drug: ABBV-901
    Intravenous (IV)
Experimental
Part 2: ABBV-901 Optimization/Expansion Dose B 		Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.
  • Drug: ABBV-901
    Intravenous (IV)
Experimental
Part 2: ABBV-901 Optimization/Expansion Dose C 		Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.
  • Drug: ABBV-901
    Intravenous (IV)
Experimental
Part 3: ABBV-901 + Bevacizumab Escalation 		Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
  • Drug: ABBV-901
    Intravenous (IV)
  • Drug: Bevacizumab
    IV
Experimental
Part 4: ABBV-901 + Bevacizumab Expansion 		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
    Intravenous (IV)
  • Drug: Bevacizumab
    IV

Recruiting Locations

Sarah Cannon Research Institute at HealthONE /ID# 278785
Denver, Colorado 80218

University of Chicago Medical Center /ID# 278295
Chicago, Illinois 60637

NEXT Oncology - San Antonio /ID# 278606
San Antonio, Texas 78229

Start Mountain Region /ID# 278609
West Valley City, Utah 84119

Next Virginia /ID# 278607
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com