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

StatusRecruiting
PhasePhase 1
SponsorAbbVie
Started

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Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
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Record History

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  1. Trial sites expanded: 24 → 27 locations
  2. Study sites: 25 to 26
  3. Study sites: 24 to 25
  4. Study sites: 23 to 24
  5. Primary endpoint(s) modified Show 4 more changesShow less
    • Enrollment increased: 219 → 285 participants
    • Trial sites expanded: 17 → 22 locations
    • Interventions modified
    • Trial arms changed: 6 → 8
Show 3 earlier versionsHide 3 earlier versions
  1. Primary endpoints revised (2) Show 8 more changesShow less
    • Enrollment target: 219 to 285
    • Study sites: 17 to 22
    • Primary completion date: Jan 2029 to Dec 2028
    • Interventions: ABBV-901 (Drug), Bevacizumab (Drug) to ABBV-901 (Drug), Bevacizumab (Drug), Carboplatin (Drug)
    • Eligibility criteria expanded, about 73 words
    • Secondary endpoints: 4 to 5
    • Study arms: 6 to 8
    • Study title expanded, about 2 words
  2. Study sites: 16 to 17v8
  3. Study sites revised (16)v7
  1. Trial sites expanded: 8 → 16 locations
    • Enrollment target: 207 to 219
    • Eligibility criteria shortened, about 7 words
    v6
  2. Study sites: 7 to 8v5
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 6 to 7v3
  5. Study sites: 5 to 6v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AbbVie
349 trials monitored
See 27 trials at risk
Ovarian Cancer
1,341 trials monitored
See 94 trials at risk
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.
Trial Details
NCT Number NCT07278336
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Ovarian Cancer
Related terms Ovarian Neoplasms
Enrollment 285 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov