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New cancer drug ABBV-400 enters early human testing

NCT ID NCT06084481

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This early-phase trial tests an investigational drug called ABBV-400 in about 300 adults with advanced solid tumors, including liver, pancreatic, breast, and ovarian cancers. The study aims to see if the drug can shrink tumors and to check for side effects. Participants receive ABBV-400 alone or with another drug (itraconazole) to understand how the body processes it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-400 (an investigational drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for several advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with a small number of participants. The drug may not shrink tumors or could cause significant side effects. It is too soon to know if it will be effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 325 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms esophageal squamous cell carcinoma fallopian tube cancer head and neck squamous cell carcinoma hepatocellular carcinoma hormone receptor-positive breast cancer ovarian carcinoma pancreatic ductal adenocarcinoma primary peritoneal carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancers Esophageal squamous cell carcinoma Head and neck squamous cell carcinoma Hepatocellular carcinoma Hormone receptor+/human epidermal growth factor receptor 2 negative breast cancer Pancreatic ductal adenocarcinoma Platinum resistant high grade epithelial ovarian cancer Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Cancer Center Hospital /ID# 256679

    COMPLETED

    Nagoya, Aichi-ken, 464-8681, Japan

  • Austin Health /ID# 256635

    COMPLETED

    Heidelberg, Victoria, 3084, Australia

  • China Medical University Hospital /ID# 256712

    COMPLETED

    Taichung, 40447, Taiwan

  • Chris O'Brien Lifehouse /ID# 262765

    COMPLETED

    Camperdown, New South Wales, 2050, Australia

  • Chungbuk National University Hospital /ID# 256698

    COMPLETED

    Cheongju-si, North Chungcheong, 28644, South Korea

  • City of Hope National Medical Center /ID# 258645

    ACTIVE_NOT_RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra - Madrid /ID# 264042

    COMPLETED

    Madrid, 28027, Spain

  • Clinica Universidad de Navarra - Pamplona /ID# 256703

    COMPLETED

    Pamplona, Navarre, 31008, Spain

  • Duke Cancer Center /ID# 255129

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • E-DA Cancer Hospital /ID# 258880

    ACTIVE_NOT_RECRUITING

    Kaohsiung City, Kaohsiung, 82445, Taiwan

  • Florida Cancer Specialists /ID# 261569

    ACTIVE_NOT_RECRUITING

    Sarasota, Florida, 34232, United States

  • Gyeongsang National University Hospital /ID# 260408

    COMPLETED

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Hadassah Medical Center-Hebrew University /ID# 256655

    ACTIVE_NOT_RECRUITING

    Jerusalem, 91120, Israel

  • Hospital General Universitario Gregorio Maranon /ID# 262816

    ACTIVE_NOT_RECRUITING

    Madrid, 28007, Spain

  • Hospital HM Nou Delfos /ID# 263953

    COMPLETED

    Barcelona, 08023, Spain

  • Hospital Quiron Malaga /ID# 263994

    COMPLETED

    Málaga, 29004, Spain

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 256702

    ACTIVE_NOT_RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 256701

    ACTIVE_NOT_RECRUITING

    Madrid, 28050, Spain

  • Hospital Universitario Miguel Servet /ID# 256704

    COMPLETED

    Zaragoza, 50009, Spain

  • Inje University Haeundae Paik Hospital /ID# 260118

    COMPLETED

    Busan, Busan Gwang Yeogsi, 48108, South Korea

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

    COMPLETED

    Fairfax, Virginia, 22031, United States

  • Institut Catala d Oncologia - ICO - Badalona /ID# 263954

    COMPLETED

    Badalona, Barcelona, 08916, Spain

  • Korea University Guro Hospital /ID# 256700

    COMPLETED

    Seoul, Seoul Teugbyeolsi, 08308, South Korea

  • Kyoto University Hospital /ID# 256680

    ACTIVE_NOT_RECRUITING

    Kyoto, Kyoto, 606-8507, Japan

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

    ACTIVE_NOT_RECRUITING

    Providence, Rhode Island, 02903-4923, United States

  • Linkou Chang Gung Memorial Hospital /ID# 259420

    COMPLETED

    Taoyuan City, 333, Taiwan

  • MD Anderson Cancer Center /ID# 255131

    COMPLETED

    Houston, Texas, 77030, United States

  • MUSC Hollings Cancer Center /ID# 257935

    COMPLETED

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 255132

    ACTIVE_NOT_RECRUITING

    New York, New York, 10065, United States

  • NHO Nagoya Medical Center /ID# 261001

    COMPLETED

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Cancer Center Hospital /ID# 261136

    ACTIVE_NOT_RECRUITING

    Chuo-Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 258934

    ACTIVE_NOT_RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Taiwan University Hospital /ID# 256713

    COMPLETED

    Taipei, 100, Taiwan

  • Northwestern University Feinberg School of Medicine /ID# 257378

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60611-2927, United States

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 262903

    COMPLETED

    Rio Piedras, 00935, Puerto Rico

  • Prisma Health /ID# 257697

    COMPLETED

    Greenville, South Carolina, 29605, United States

  • Rabin Medical Center. /ID# 256650

    COMPLETED

    Petah Tikva, Central District, 4941492, Israel

  • Rambam Health Care Campus /ID# 256649

    ACTIVE_NOT_RECRUITING

    Haifa, 3109601, Israel

  • START Midwest /ID# 256581

    ACTIVE_NOT_RECRUITING

    Grand Rapids, Michigan, 49546-7062, United States

  • START-San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Samsung Medical Center /ID# 258933

    COMPLETED

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

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

    ACTIVE_NOT_RECRUITING

    Denver, Colorado, 80218, United States

  • Seoul National University Hospital /ID# 255730

    COMPLETED

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shizuoka Cancer Center /ID# 257789

    ACTIVE_NOT_RECRUITING

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Tel Aviv Sourasky Medical Center /ID# 258931

    COMPLETED

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Tennessee Oncology-Nashville Centennial /ID# 261568

    ACTIVE_NOT_RECRUITING

    Nashville, Tennessee, 37203-1632, United States

  • The Cancer Institute Hospital Of JFCR /ID# 257788

    ACTIVE_NOT_RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Chaim Sheba Medical Center /ID# 255731

    COMPLETED

    Ramat Gan, Tel Aviv, 5265601, Israel

  • UCSF Medical Center - Mount Zion /ID# 257705

    COMPLETED

    San Francisco, California, 94115, United States

  • Univ Hosp Cleveland /ID# 257706

    ACTIVE_NOT_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Univ Texas HSC San Antonio /ID# 257708

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229-3901, United States

  • University of Chicago Medical Center /ID# 258197

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60637, United States

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

    COMPLETED

    Aurora, Colorado, 80045-7158, United States

  • Washington University-School of Medicine /ID# 257379

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.