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NCT06084481

PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

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) followed by a safety follow-up period. Cohort 9 receives ABBV-400 in combination with a strong CYP3A3 inhibitor (ITZ) followed by a safety follow-up period. Approximately 285 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 and in cohort 9 participants will receive intravenous (IV) ABBV-400 and an oral solution of 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. 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.

Official title: A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

302

Start Date

2023-11-09

Completion Date

2026-07

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Hepatocellular Carcinoma Pancreatic Ductal Adenocarcinoma Biliary Tract Cancers Esophageal Squamous Cell Carcinoma Triple Negative Breast Cancer Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Head and Neck Squamous-Cell Carcinoma Platinum Resistant High Grade Epithelial Ovarian Cancer

Interventions

DRUG

ABBV-400

Intravenous (IV) Infusion

DRUG

Itraconazole (ITZ)

Oral Solution

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.

Locations (54)

City of Hope National Medical Center /ID# 258645

Duarte, California, United States

Ucsf /Id# 257705

San Francisco, California, United States

University of Colorado Cancer Center - Cancer Clinical Trials Office /ID# 255128

Aurora, Colorado, United States

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

Denver, Colorado, United States

Florida Cancer Specialists /ID# 261569

Sarasota, Florida, United States

Northwestern University Feinberg School of Medicine /ID# 257378

Chicago, Illinois, United States

University of Chicago Medical Center /ID# 258197

Chicago, Illinois, United States

START Midwest /ID# 256581

Grand Rapids, Michigan, United States

Washington University-School of Medicine /ID# 257379

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255132

New York, New York, United States

Duke Cancer Center /ID# 255129

Durham, North Carolina, United States

Univ Hosp Cleveland /ID# 257706

Cleveland, Ohio, United States

Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693

Providence, Rhode Island, United States

MUSC Hollings Cancer Center /ID# 257935

Charleston, South Carolina, United States

Prisma Health /ID# 257697

Greenville, South Carolina, United States

Tennessee Oncology-Nashville Centennial /ID# 261568

Nashville, Tennessee, United States

MD Anderson Cancer Center /ID# 255131

Houston, Texas, United States

Univ Texas HSC San Antonio /ID# 257708

San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics /ID# 260404

San Antonio, Texas, United States

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

Fairfax, Virginia, United States

Chris O'Brien Lifehouse /ID# 262765

Camperdown, New South Wales, Australia

Austin Health /ID# 256635

Heidelberg, Victoria, Australia

The Chaim Sheba Medical Center /ID# 255731

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 258931

Tel Aviv, Tel Aviv, Israel

Rambam Health Care Campus /ID# 256649

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 256655

Jerusalem, Israel

Rabin Medical Center. /ID# 256650

Petah Tikva, Israel

NHO Nagoya Medical Center /ID# 261001

Nagoya, Aichi-ken, Japan

Aichi Cancer Center Hospital /ID# 256679

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East /ID# 258934

Kashiwa-shi, Chiba, Japan

Kyoto University Hospital /ID# 256680

Kyoto, Kyoto, Japan

Shizuoka Cancer Center /ID# 257789

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital /ID# 261136

Chuo-Ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR /ID# 257788

Koto-ku, Tokyo, Japan

Pan American Center for Oncology Trials /ID# 262903

Rio Piedras, Puerto Rico

Inje University Haeundae Paik Hospital /ID# 260118

Busan, Busan Gwang Yeogsi, South Korea

Gyeongsang National University Hospital /ID# 260408

Jinju, Gyeongsangnam-do, South Korea

Chungbuk National University Hospital /ID# 256698

Cheongju-si, North Chungcheong, South Korea

Seoul National University Hospital /ID# 255730

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 258933

Seoul, Seoul Teugbyeolsi, South Korea

Korea University Guro Hospital /ID# 256700

Seoul, Seoul Teugbyeolsi, South Korea

Institut Català d'Oncologia (ICO) - Badalona /ID# 263954

Badalona, Barcelona, Spain

Hospital Quirón Málaga /ID# 263994

Málaga, Malaga, Spain

Clinica Universidad de Navarra - Pamplona /ID# 256703

Pamplona, Navarre, Spain

Hospital HM Nou Delfos /ID# 263953

Barcelona, Spain

Hospital General Universitario Gregorio Maranon /ID# 262816

Madrid, Spain

Clinica Universidad de Navarra - Madrid /ID# 264042

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 256702

Madrid, Spain

Hospital Universitario HM Sanchinarro /ID# 256701

Madrid, Spain

Hospital Universitario Miguel Servet /ID# 256704

Zaragoza, Spain

E-DA Cancer Hospital /ID# 258880

Kaohsiung City, Kaohsiung, Taiwan

National Taiwan University Hospital /ID# 256713

Taipei City, Taipei, Taiwan

China Medical University Hospital /ID# 256712

Taichung, Taiwan

Linkou Chang Gung Memorial Hospital /ID# 259420

Taoyuan, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (54)