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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
AbbVie
Study ID
NCT07278336
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-901 — DRUG
    Intravenous (IV)
  • Bevacizumab — DRUG
    IV

Study Details

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 207 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.

Key Dates

Start date
Nov 27, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
207 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Number of Participants with Adverse Events (AE) [ Time Frame: Up to Approximately 3 Years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
NEXT Oncology - San Antonio /ID# 278606San AntonioTexas78229-
Start Mountain Region /ID# 278609West Valley CityUtah84119-
Next Virginia /ID# 278607FairfaxVirginia22031-

Find similar trials in San Antonio, TX

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
NEXT Oncology - San Antonio· San Antonio, TXStart Mountain Region· West Valley City, UTNext Virginia· Fairfax, VA

Related Studies