Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06084481
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ABBV-400 — DRUG
    Intravenous (IV) Infusion
  • Itraconazole (ITZ) — DRUG
    Oral Solution
  • Bevacizumab — DRUG
    IV Infusion

Study Details

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV bevacizumab, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key Dates

First listed
Oct 16, 2023
Start date
Nov 9, 2023
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
325 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Hepatocellular Carcinoma (HCC)
    Participants with HCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC)
    Participants with PDAC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 3: Biliary Tract Cancers (BTC)
    Participants with BTC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC)
    Participants with ESCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 5: Triple Negative Breast Cancer (TNBC)
    Participants with TNBC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
    Participants with HR+/HER2-BC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC)
    Participants with HNSCC will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 8: PROC/Primary Peritoneal/Fallopian Tube Cancer
    Participants with Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer will receive ABBV-400 for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 9: Drug-Drug Interaction
    Participants with advanced or metastatic solid tumors will receive ABBV-400 and a strong CYP3A4 inhibitor (ITZ) for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Experimental: Cohort 10: PROC/Primary Peritoneal/Fallopian Tube Cancer
    Participants with PROC/primary peritoneal/fallopian tube cancer will receive ABBV-400 in combination with bevacizumab for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 36 Months ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 258645DuarteCalifornia91010-
UCSF Medical Center - Mount Zion /ID# 257705San FranciscoCalifornia94115-
University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128AuroraColorado80045-7158-
Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926DenverColorado80218-
Florida Cancer Specialists /ID# 261569SarasotaFlorida34232-
Northwestern University Feinberg School of Medicine /ID# 257378ChicagoIllinois60611-2927-
University of Chicago Medical Center /ID# 258197ChicagoIllinois60637-
START Midwest /ID# 256581Grand RapidsMichigan49546-7062-
Washington University-School of Medicine /ID# 257379St LouisMissouri63110-
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132New YorkNew York10065-
Duke Cancer Center /ID# 255129DurhamNorth Carolina27710-
Univ Hosp Cleveland /ID# 257706ClevelandOhio44106-
Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693ProvidenceRhode Island02903-4923-
MUSC Hollings Cancer Center /ID# 257935CharlestonSouth Carolina29425-
Prisma Health /ID# 257697GreenvilleSouth Carolina29605-
Tennessee Oncology-Nashville Centennial /ID# 261568NashvilleTennessee37203-1632-
MD Anderson Cancer Center /ID# 255131HoustonTexas77030-
START-San AntonioSan AntonioTexas78229
HOPE Team
[email protected]
210-593-5250
Dr. Papadopoulos (PRINCIPAL_INVESTIGATOR)
Univ Texas HSC San Antonio /ID# 257708San AntonioTexas78229-3901-
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771FairfaxVirginia22031-

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