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New hope for advanced cancers: ABBV-400 enters human trials

NCT ID NCT05029882

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase study tests an experimental drug called ABBV-400, alone or with another drug (bevacizumab), in about 520 adults with advanced solid tumors including lung, stomach, and colorectal cancers. The goal is to find the safest and most effective dose and see if it can shrink tumors. Participants receive the drug through an IV and are closely monitored for side effects and disease changes.

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

520 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Nov 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: * Diagnosis of malignant solid tumor (World Health Organization \[WHO\] criteria). * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * For Part 1 only - advanced solid tumors including (but not limited to) non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renal cell carcinoma (RCC), who have progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * For Part 2 only - advanced non-squamous squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least: * Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR NSCLC (Part 2i) and squamous NSCLC (Part 2iii). * Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI\[s\]) for non- squamous mutEGFR NSCLC (Part 2ii). * Must have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * For Part 3 only - Participants with advanced GEA that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on * If applicable, an immune checkpoint inhibitor. * If applicable, appropriate available therapies, including HER2-directed therapies. Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. * For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on: * A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine). * Oxaliplatin. * Irinotecan. * If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab). * If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept). * If applicable, targeted therapy * Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior trifluridine/tipiracil (TAS-102) or Regorafenib treated participants are eligible. * For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible. For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. * Intolerant to the standard treatment are eligible * For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H with progression on: * A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine) * Oxaliplatin * Irinotecan * If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab) * If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept) * If applicable, targeted therapy Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Participants treated previously with TAS-102 or regorafenib are not eligible. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Laboratory values meeting the criteria outlined in the protocol. Exclusion Criteria: * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or on screening chest CT scan.. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * History of clinically significant, intercurrent lung-specific illnesses, as noted in the protocol. * For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastroesophageal adenocarcinoma head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

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

Advanced solid tumors Colorectal cancer Gastroesophageal adenocarcinoma Non-small cell lung cancer

Contacts and locations

Locations

  • AP-HP - Hopital Européen Georges Pompidou /ID# 250481

    Paris, 75015, France

  • Aichi Cancer Center Hospital /ID# 250284

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center /ID# 245215

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Austin Health /ID# 247667

    Heidelberg, Victoria, 3084, Australia

  • CHA Bundang Medical Center /ID# 247115

    Seongnam, Gyeonggido, 13496, South Korea

  • CHU Nantes - Hopital Laennec /ID# 244723

    Saint-Herblain, Loire-Atlantique, 44800, France

  • Carolina BioOncology Institute /ID# 231541

    Huntersville, North Carolina, 28078, United States

  • Centre Antoine-Lacassagne /ID# 231730

    Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

  • Centre Georges François Leclerc /ID# 244450

    Dijon, 21079, France

  • Centre Leon Berard /ID# 250987

    Lyon, Rhone, 69373, France

  • Changhua Christian Hospital /ID# 249150

    Changhua City, Changhua County, 50006, Taiwan

  • Chungbuk National University Hospital /ID# 245168

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clinica Universidad de Navarra - Pamplona /ID# 248816

    Pamplona, Navarre, 31008, Spain

  • Cmuh /Id# 245729

    Taichung, 40701, Taiwan

  • Community Health Network, Inc. /ID# 245331

    Indianapolis, Indiana, 46250-2042, United States

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 245378

    Santiago de Compostela, A Coruna, 15706, Spain

  • Comprehensive Cancer Centers of Nevada /ID# 242930

    Henderson, Louisiana, 89052, United States

  • Duke Cancer Institute /ID# 247236

    Durham, North Carolina, 27710, United States

  • Duplicate_Gabrail Cancer Center Research /ID# 248419

    Canton, Ohio, 44718, United States

  • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 246449

    Kaohsiung City, Kaohsiung, 833, Taiwan

  • Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338

    Fort Wayne, Indiana, 46825, United States

  • Gyeongsang National University Hospital /ID# 248420

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Hadassah Medical Center /ID# 243821

    Jerusalem, Jerusalem, 91120, Israel

  • Hospital Clinic de Barcelona /ID# 245374

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon /ID# 245270

    Madrid, 28007, Spain

  • Hospital Universitario 12 de Octubre /ID# 248417

    Madrid, 28041, Spain

  • Hospital Universitario Fundacion Alcorcon /ID# 244505

    Alcorcón, Madrid, 28922, Spain

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 231464

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 244721

    Madrid, 28050, Spain

  • Hospital Universitario Miguel Servet /ID# 244456

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall de Hebron /ID# 249809

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena /ID# 245213

    Seville, 41009, Spain

  • Hospital Universitario de Jaen /ID# 249201

    Jaén, 23007, Spain

  • Indiana University Melvin and Bren Simon Cancer Center /ID# 245133

    Indianapolis, Indiana, 46202-5112, United States

  • Inje University Haeundae Hospital /ID# 244451

    Busan, Busan Gwang Yeogsi, 48108, South Korea

  • Institut Bergonie /ID# 248028

    Bordeaux, Gironde, 33000, France

  • Institut Gustave Roussy /ID# 246824

    Villejuif, Val-de-Marne, 94805, France

  • Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399

    Saint-Herblain, Loire-Atlantique, 44805, France

  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 245379

    Badalona, Barcelona, 08916, Spain

  • Kangbuk Samsung Hospital /ID# 248401

    Seoul, Seoul Teugbyeolsi, 03181, South Korea

  • Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917

    Taipei, 112, Taiwan

  • Korea University Guro Hospital /ID# 244504

    Seoul, Seoul Teugbyeolsi, 08308, South Korea

  • Kyoto University Hospital /ID# 250291

    Kyoto, Kyoto, 606-8507, Japan

  • Linkou Chang Gung Memorial Hospital /ID# 248716

    Taoyuan City, 333, Taiwan

  • MD Anderson Cancer Center at Texas Medical Center /ID# 248656

    Houston, Texas, 77030-4000, United States

  • Mater Misericordiae Limited /ID# 249995

    South Brisbane, Queensland, 4101, Australia

  • Med Polonia Sp. z o. o. /ID# 250799

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Meir Medical Center /ID# 244179

    Kfar Saba, Central District, 4428164, Israel

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668

    New York, New York, 10065-6007, United States

  • NEXT Oncology /ID# 231578

    San Antonio, Texas, 78229, United States

  • NHO Nagoya Medical Center /ID# 250286

    Nagoya, Aichi-ken, 460-0001, Japan

  • Nagasaki University Hospital /ID# 250290

    Nagasaki, 852-8501, Japan

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 246569

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Center Hospital /ID# 232007

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 232008

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital /ID# 245918

    Tainan, 704, Taiwan

  • National Taiwan University Hospital /ID# 245731

    Taipei City, Taipei, 100, Taiwan

  • Niigata University Medical & Dental Hospital /ID# 250952

    Niigata, Niigata, 951-8520, Japan

  • Northwest Medical Specialties Tacoma /ID# 267339

    Tacoma, Washington, 98405, United States

  • Oncology Consultants /ID# 267347

    Houston, Texas, 77030, United States

  • Pan American Center for Oncology Trials, LLC /ID# 231580

    Rio Piedras, 00935, Puerto Rico

  • Rabin Medical Center /ID# 243363

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus /ID# 231218

    Haifa, 3109601, Israel

  • SMG-SNU Boramae Medical Center /ID# 248421

    Seoul, Seoul Teugbyeolsi, 07061, South Korea

  • START Midwest /ID# 231551

    Grand Rapids, Michigan, 49546-7062, United States

  • Samodzielny Publiczny Zespó? Gru?licy i Chorób P?uc w Olsztynie /ID# 250466

    Olsztyn, 10-357, Poland

  • Seoul National University Hospital /ID# 244667

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Taipei Medical University Hospital /ID# 245732

    Taipei, 11031, Taiwan

  • Taipei Veterans General Hosp /ID# 250652

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center /ID# 245271

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Cancer Institute Hospital Of JFCR /ID# 248447

    Koto-ku, Tokyo, 135-8550, Japan

  • The Chaim Sheba Medical Center /ID# 231217

    Ramat Gan, Tel Aviv, 5265601, Israel

  • Tri-Service General Hospital /ID# 245733

    Taipei, 114, Taiwan

  • University Of Colorado Denver /ID# 231574

    Aurora, Colorado, 80045-2530, United States

  • University of California, Los Angeles /ID# 243841

    Los Angeles, California, 90095, United States

  • University of Illinois Hospital and Health Sciences System /ID# 251386

    Chicago, Illinois, 60607, United States

  • Virginia Cancer Specialists - Fairfax /ID# 231575

    Fairfax, Virginia, 22031, United States

  • Wakayama Medical University Hospital /ID# 250283

    Wakayama, Wakayama, 641-8510, Japan

  • Wojewodzki Szpital im. Sw. Ojca Pio /ID# 251846

    Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

  • Yale School of Medicine /ID# 248418

    New Haven, Connecticut, 06519, United States

  • Yokohama Municipal Citizen's Hospital /ID# 248842

    Yokohama, Kanagawa, 221-0855, Japan

  • Yonsei University Health System Severance Hospital /ID# 245218

    Seoul, 03722, South Korea

More trials for these conditions

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