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NCT05029882Active, not recruitingPhase 1

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors

Source: ClinicalTrials.gov · Last updated 29 Oct 2025

Brief summary (registry, in English)

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 treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose and combination with bevacizumab. Approximately 500 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. Dose escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. Dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) \[Part 2i\] or mutated EGFR-expression (mutEGFR NSCLC) \[Part 2ii\], squamous NSCLC \[Part 2iii\], GEA \[Part 3\] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive IV ABBV-400 monotherapy in expansion \[Part 4\], participants MET amplification will receive IV ABBV-400 monotherapy in expansion \[Part 5\], participants MET mutation will receive IV ABBV-400 monotherapy in expansion \[Part 6\], participants CRC safety lead in will receive escalating doses of IV ABBV-400 in combination with IV bevacizumab \[Part 7a\], and participants CRC dose optimization in will the low or high dose of IV ABBV-400 determined in Part 7a in combination with IV bevacizumab or oral trifluridine/tipiracil (TAS-102) tablets \[Part 7b\]. 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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
520 (actual)
First submitted
30 Aug 2021
Start date
13 Oct 2021
Primary completion date
30 Nov 2027
Lead sponsor
AbbVie
NCT number
NCT05029882
EU CT number
2023-509335-60-00
EudraCT number
2021-002258-98

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 520
  • From 13 Oct 2021 to the primary completion date, 30 Nov 2027
  • 81 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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..
  • For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (81)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Austin Health /ID# 247667
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HeidelbergAustraliaUnknown status
Mater Misericordiae Limited /ID# 249995
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South BrisbaneAustraliaUnknown status
Charite Research Organisation GmbH
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BerlinGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Giessen und Marburg GmbH
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GiessenGermanyCompleted
Hospital Universitario Fundación Alcorcón
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AlcorcónSpainActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario de Jaén
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JaénSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainActive, not recruiting
Institut Bergonie
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BordeauxFranceActive, not recruiting
Centr Georges Francois Leclerc
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DijonFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceActive, not recruiting
Institut Gustave Roussy
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Villejuif CedexFranceActive, not recruiting
Rambam Health Care Campus /ID# 231218
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HaifaIsraelUnknown status
Hadassah Medical Center /ID# 243821
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JerusalemIsraelUnknown status
Meir Medical Center /ID# 244179
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Kfar SabaIsraelUnknown status
Rabin Medical Center /ID# 243363
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 231217
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 245271
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Tel AvivIsraelUnknown status
National Cancer Center Hospital /ID# 232007
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Chuo-kuJapanUnknown status
National Cancer Center Hospital East /ID# 232008
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Kashiwa-shiJapanUnknown status
The Cancer Institute Hospital Of JFCR /ID# 248447
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Koto-kuJapanUnknown status
Kyoto University Hospital /ID# 250291
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KyotoJapanUnknown status
Nagasaki University Hospital /ID# 250290
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NagasakiJapanUnknown status
Aichi Cancer Center Hospital /ID# 250284
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NagoyaJapanUnknown status
NHO Nagoya Medical Center /ID# 250286
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NagoyaJapanUnknown status
Niigata University Medical & Dental Hospital /ID# 250952
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NiigataJapanUnknown status
Wakayama Medical University Hospital /ID# 250283
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WakayamaJapanUnknown status
Yokohama Municipal Citizen's Hospital /ID# 248842
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YokohamaJapanUnknown status
Inje University Haeundae Hospital /ID# 244451
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BusanSouth KoreaUnknown status
Chungbuk National University Hospital /ID# 245168
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Cheongju-siSouth KoreaUnknown status
Gyeongsang National University Hospital /ID# 248420
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JinjuSouth KoreaUnknown status
CHA Bundang Medical Center /ID# 247115
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SeongnamSouth KoreaUnknown status
SMG-SNU Boramae Medical Center /ID# 248421
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital /ID# 248401
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SeoulSouth KoreaUnknown status
Asan Medical Center /ID# 245215
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SeoulSouth KoreaUnknown status
Yonsei University Health System Severance Hospital /ID# 245218
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 244667
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SeoulSouth KoreaUnknown status
Korea University Guro Hospital /ID# 244504
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SeoulSouth KoreaUnknown status
Med Polonia Sp z o.o.
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PoznanPolandActive, not recruiting
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
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PrzemyślPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Pan American Center for Oncology Trials, LLC /ID# 231580
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Rio PiedrasPuerto RicoUnknown status
Changhua Christian Hospital /ID# 249150
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Changhua City, Changhua CountyTaiwanUnknown status
Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 246449
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Kaohsiung CityTaiwanUnknown status
Cmuh /Id# 245729
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital /ID# 245918
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TainanTaiwanUnknown status
Taipei Medical University Hospital /ID# 245732
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TaipeiTaiwanUnknown status
Tri-Service General Hospital /ID# 245733
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TaipeiTaiwanUnknown status
Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917
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TaipeiTaiwanUnknown status
Taipei Veterans General Hosp /ID# 250652
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TaipeiTaiwanUnknown status
National Taiwan University Hospital /ID# 245731
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Taipei CityTaiwanUnknown status
Linkou Chang Gung Memorial Hospital /ID# 248716
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Taoyuan CityTaiwanUnknown status
University Of Colorado Denver /ID# 231574
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AuroraUnited StatesUnknown status
Duplicate_Gabrail Cancer Center Research /ID# 248419
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CantonUnited StatesUnknown status
University of Illinois Hospital and Health Sciences System /ID# 251386
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ChicagoUnited StatesUnknown status
Duke Cancer Institute /ID# 247236
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DurhamUnited StatesUnknown status
Virginia Cancer Specialists - Fairfax /ID# 231575
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FairfaxUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338
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Fort WayneUnited StatesUnknown status
START Midwest /ID# 231551
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Grand RapidsUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada /ID# 242930
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HendersonUnited StatesUnknown status
Oncology Consultants /ID# 267347
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HoustonUnited StatesUnknown status
MD Anderson Cancer Center at Texas Medical Center /ID# 248656
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HoustonUnited StatesUnknown status
Carolina BioOncology Institute /ID# 231541
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HuntersvilleUnited StatesUnknown status
Community Health Network, Inc. /ID# 245331
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IndianapolisUnited StatesUnknown status
Indiana University Melvin and Bren Simon Cancer Center /ID# 245133
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IndianapolisUnited StatesUnknown status
University of California, Los Angeles /ID# 243841
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Los AngelesUnited StatesUnknown status
Yale School of Medicine /ID# 248418
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New HavenUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668
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New YorkUnited StatesUnknown status
NEXT Oncology /ID# 231578
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San AntonioUnited StatesUnknown status
Northwest Medical Specialties Tacoma /ID# 267339
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TacomaUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.