A Phase 1 First-in-Human, Open-Label Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-901 as a Monotherapy and in Combination With Bevacizumab in Adult Subjects With Ovarian Cancer

Study Identifier:
M25-760
CT.gov Identifier:
NCT07278336
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study 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 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Ovarian
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Part 1: ABBV-901 Dose Escalation
    • Read More
  • Drug: Participants will receive escalating doses of ABBV-901 alone, as part of the approximately 3 year study duration.
  • Drug: Drug: ABBV-901
  • Drug: Intravenous (IV)
  • Drug: EXPERIMENTAL: Part 2: ABBV-901 Optimization/Expansion Dose A
  • Drug: Participants will receive ABBV-901 dose A alone, as part of the approximately 3 year study duration.
  • Drug: EXPERIMENTAL: Part 2: ABBV-901 Optimization/Expansion Dose B
  • Drug: Participants will receive ABBV-901 dose B alone, as part of the approximately 3 year study duration.
  • Drug: EXPERIMENTAL: Part 2: ABBV-901 Optimization/Expansion Dose C
  • Drug: Participants will receive ABBV-901 dose C alone, as part of the approximately 3 year study duration.
  • Drug: EXPERIMENTAL: Part 3: ABBV-901 + Bevacizumab Escalation
  • Drug: Participants will receive escalating doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
  • Drug: Drug: Bevacizumab
  • Drug: IV
  • Drug: EXPERIMENTAL: Part 4: ABBV-901 + Bevacizumab Expansion
  • Drug: Participants will receive the recommended doses for expansion doses of ABBV-901 in combination Bevacizumab, as part of the approximately 3 year study duration.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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. 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 5 prior lines of therapy, with clinical progression of disease on no more than 2 prior therapies since the development of platinum resistance.
    • * 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, nor 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian