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

Last updated: March 6, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatic Fibrosis

Ovarian Cysts

Esophageal Cancer

Treatment

ABBV-400

Clinical Study ID

NCT06084481
M24-427
2023-506227-29-00
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

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 necksquamous-cell-carcinoma (HNSCC), or Platinum Resistant High Grade Epithelial OvarianCancer (PROC)/primary peritoneal/fallopian tube cancer (by World Health Organization [WHO] criteria). Participant meets the criteria for disease activity laid out in theprotocol.

Exclusion

Exclusion Criteria:

  • Have received anticancer therapy including chemotherapy, radiation therapy,immunotherapy, biologic, or any investigational therapy within 28 days or 5half-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 10fractions 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 treatmentwith systemic steroids, or any evidence of active ILD or pneumonitis, including butnot limited to those listed in the protocol.

  • History of clinically significant, intercurrent lung-specific illnesses, includingthose laid out in the protocol.

  • Untreated brain or meningeal metastases (i.e., participants with history ofmetastases are eligible provided they do not require ongoing steroid treatment forcerebral edema and have shown clinical and radiographic stability for at least 14days after definitive therapy). Participants may continue on antiepileptic therapyif required.

  • History of other active malignancy, with the exception of those laid out in theprotocol.

  • Any autoimmune, connective tissue or inflammatory disorders with documented orsuspicious pulmonary involvement at screening (i.e., rheumatoid arthritis,Sjogren's, sarcoidosis etc.), and prior pneumonectomy.

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: ABBV-400
Phase: 1
Study Start date:
November 09, 2023
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Chris O'Brien Lifehouse /ID# 262765

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Austin Health /ID# 256635

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Rambam Health Care Campus /ID# 256649

    Haifa, H_efa 3109601
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 255731

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 258931

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 256650

    Haifa, 4941492
    Israel

    Active - Recruiting

  • Hadassah Medical Center /ID# 256655

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah Medical Center-Hebrew University /ID# 256655

    Jerusalem, 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 256650

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Aichi Cancer Center Hospital /ID# 256679

    Nagoya-shi, Aichi 464-8681
    Japan

    Active - Recruiting

  • NHO Nagoya Medical Center /ID# 261001

    Nagoya-shi, Aichi 460-0001
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East /ID# 258934

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • Kyoto University Hospital /ID# 256680

    Kyoto-shi, Kyoto 606-8507
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center /ID# 257789

    Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital /ID# 261136

    Chuo-Ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital Of JFCR /ID# 257788

    Koto, Tokyo 135-8550
    Japan

    Site Not Available

  • The Cancer Institute Hospital Of JFCR /ID# 257788

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Inje University Haeundae Paik Hospital /ID# 260118

    Busan, Busan Gwang Yeogsi 48108
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital /ID# 256698

    Cheongju, Chungcheongbugdo 28644
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospital /ID# 260408

    Jinju, Gyeongsangnamdo 52727
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital /ID# 256700

    Seoul, Seoul Teugbyeolsi 08308
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center /ID# 258933

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital /ID# 255730

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Pan American Center for Oncology Trials /ID# 262903

    Rio Piedras, 00935
    Puerto Rico

    Active - Recruiting

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

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital Quirón Málaga /ID# 263994

    Málaga, Malaga 29004
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona /ID# 256703

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital HM Nou Delfos /ID# 263953

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Madrid /ID# 264042

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón /ID# 262816

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz /ID# 256702

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro /ID# 256701

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet /ID# 256704

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • E-DA Cancer Hospital /ID# 258880

    Kaohsiung City, Kaohsiung 82445
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital /ID# 256713

    Taipei City, Taipei 100
    Taiwan

    Active - Recruiting

  • China Medical University Hospital /ID# 256712

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital /ID# 259420

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • City of Hope National Medical Center /ID# 258645

    Duarte, California 91010
    United States

    Active - Recruiting

  • Ucsf /Id# 257705

    San Francisco, California 94143
    United States

    Active - Recruiting

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

    Aurora, Colorado 80045-7158
    United States

    Completed

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

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists /ID# 261569

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine /ID# 257378

    Chicago, Illinois 60611-2927
    United States

    Active - Recruiting

  • The University of Chicago Medical Center /ID# 258197

    Chicago, Illinois 60637-1443
    United States

    Active - Recruiting

  • University of Chicago Medical Center /ID# 258197

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • START Midwest /ID# 256581

    Grand Rapids, Michigan 49546-7062
    United States

    Active - Recruiting

  • Washington University-School of Medicine /ID# 257379

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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

    New York, New York 10065-6007
    United States

    Active - Recruiting

  • Duke Cancer Center /ID# 255129

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Univ Hosp Cleveland /ID# 257706

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Lifespan Cancer Institute at Rhode Island Hospital /ID# 257693

    Providence, Rhode Island 02903-4923
    United States

    Active - Recruiting

  • MUSC Hollings Cancer Center /ID# 257935

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Prisma Health /ID# 257697

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute-Faris Road /ID# 257697

    Greenville, South Carolina 29605-4255
    United States

    Active - Recruiting

  • Tennessee Oncology-Nashville Centennial /ID# 261568

    Nashville, Tennessee 37203-1632
    United States

    Active - Recruiting

  • MD Anderson Cancer Center /ID# 255131

    Houston, Texas 77030
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics /ID# 260404

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics/ ID# 260404

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Univ Texas HSC San Antonio /ID# 257708

    San Antonio, Texas 78229-3901
    United States

    Active - Recruiting

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

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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