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Purpose

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. Each cohort receives ABBV-400 alone (monotherapy) followed by a safety follow-up period. Approximately 260 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 the each cohorts, 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 for up to 2 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.

Conditions

Eligibility

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

Inclusion Criteria

  • Laboratory values meeting the criteria laid out in the protocol. - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Documented diagnosis of locally advanced or metastatic hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), squamous cell carcinoma of the esophagus, (ESCC), triple negative breast cancer (TNBC), hormone receptor+/HER2-breast cancer (HR+/HER2-BC), head and neck squamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in the protocol.

Exclusion Criteria

  • Have received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400. Palliative radiation therapy for bone, skin, or subcutaneous metastases with 10 fractions or less is permitted and not subject to a washout period. - Unresolved clinically significant AEs > Grade 1 from prior anticancer therapy. - History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis, including but not limited to those listed in the protocol. - History of clinically significant, intercurrent lung-specific illnesses, including those laid out in the protocol. - Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue on antiepileptic therapy if required. - History of other active malignancy, with the exception of those laid out in the protocol. - Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Hepatocellular Carcinoma (HCC) 		Participants with HCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
Experimental
Cohort 2: Pancreatic Ductal Adenocarcinoma (PDAC) 		Participants with PDAC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
Experimental
Cohort 3: Biliary Tract Cancers (BTC) 		Participants with BTC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
Experimental
Cohort 4: Esophageal Squamous Cell Carcinoma, (ESCC) 		Participants with ESCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
Experimental
Cohort 5: Triple Negative Breast Cancer (TNBC) 		Participants with TNBC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
Experimental
Cohort 6: Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC) 		Participants with HR+/HER2-BC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
Experimental
Cohort 7: Head and Neck Squamous-cell-carcinoma (HNSCC) 		Participants with HNSCC will receive ABBV-400 for up to 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion
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 2 years during and up to the treatment period with an additional safety follow-up period of up to 2 years.
  • Drug: ABBV-400
    Intravenous (IV) Infusion

Recruiting Locations

City of Hope National Medical Center /ID# 258645
Duarte, California 91010

Ucsf /Id# 257705
San Francisco, California 94143

Sarah Cannon Research Institute at HealthONE - Denver /ID# 258926
Denver, Colorado 80218

Florida Cancer Specialists /ID# 261569
Sarasota, Florida 34232

Northwestern University Feinberg School of Medicine /ID# 257378
Chicago, Illinois 60611-2927

University of Chicago Medical Center /ID# 258197
Chicago, Illinois 60637

START Midwest /ID# 256581
Grand Rapids, Michigan 49546-7062

Washington University-School of Medicine /ID# 257379
Saint Louis, Missouri 63110

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132
New York, New York 10065-6007

Duke Cancer Center /ID# 255129
Durham, North Carolina 27710

Univ Hosp Cleveland /ID# 257706
Cleveland, Ohio 44106

Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693
Providence, Rhode Island 02903-4923

MUSC Hollings Cancer Center /ID# 257935
Charleston, South Carolina 29425

Prisma Health /ID# 257697
Greenville, South Carolina 29605

Tennessee Oncology-Nashville Centennial /ID# 261568
Nashville, Tennessee 37203-1632

MD Anderson Cancer Center /ID# 255131
Houston, Texas 77030

Univ Texas HSC San Antonio /ID# 257708
San Antonio, Texas 78229-3901

South Texas Accelerated Research Therapeutics /ID# 260404
San Antonio, Texas 78229

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 262771
Fairfax, Virginia 22031

Pan American Center for Oncology Trials /ID# 262903
Rio Piedras, Puerto Rico 00935

More Details

NCT ID
NCT06084481
Status
Recruiting
Sponsor
AbbVie

Study Contact

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

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