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
- Diseases
- Head and neck cancer, Kidney cancer, Lung cancer, Colorectal cancer, Gastric and esophageal cancer
- 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
Sites (81)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health /ID# 247667 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Mater Misericordiae Limited /ID# 249995 Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Giessen | Germany | Completed |
| Hospital Universitario Fundación Alcorcón Coordinator of this site? Confirm its status | Alcorcón | Spain | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario de Jaén Coordinator of this site? Confirm its status | Jaén | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centr Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | Saint-Herblain Cedex | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif Cedex | France | Active, not recruiting |
| Rambam Health Care Campus /ID# 231218 Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center /ID# 243821 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Meir Medical Center /ID# 244179 Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin Medical Center /ID# 243363 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 231217 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel Aviv Sourasky Medical Center /ID# 245271 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| National Cancer Center Hospital /ID# 232007 Coordinator of this site? Confirm its status | Chuo-ku | Japan | Unknown status |
| National Cancer Center Hospital East /ID# 232008 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| The Cancer Institute Hospital Of JFCR /ID# 248447 Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| Kyoto University Hospital /ID# 250291 Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Nagasaki University Hospital /ID# 250290 Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Aichi Cancer Center Hospital /ID# 250284 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| NHO Nagoya Medical Center /ID# 250286 Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Niigata University Medical & Dental Hospital /ID# 250952 Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Wakayama Medical University Hospital /ID# 250283 Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Yokohama Municipal Citizen's Hospital /ID# 248842 Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Inje University Haeundae Hospital /ID# 244451 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungbuk National University Hospital /ID# 245168 Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Gyeongsang National University Hospital /ID# 248420 Coordinator of this site? Confirm its status | Jinju | South Korea | Unknown status |
| CHA Bundang Medical Center /ID# 247115 Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| SMG-SNU Boramae Medical Center /ID# 248421 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital /ID# 248401 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center /ID# 245215 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 245218 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 244667 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital /ID# 244504 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu Coordinator of this site? Confirm its status | Przemyśl | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Pan American Center for Oncology Trials, LLC /ID# 231580 Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Changhua Christian Hospital /ID# 249150 Coordinator of this site? Confirm its status | Changhua City, Changhua County | Taiwan | Unknown status |
| Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 246449 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Cmuh /Id# 245729 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital /ID# 245918 Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Medical University Hospital /ID# 245732 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital /ID# 245733 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hosp /ID# 250652 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital /ID# 245731 Coordinator of this site? Confirm its status | Taipei City | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital /ID# 248716 Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| University Of Colorado Denver /ID# 231574 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Duplicate_Gabrail Cancer Center Research /ID# 248419 Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| University of Illinois Hospital and Health Sciences System /ID# 251386 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Duke Cancer Institute /ID# 247236 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Virginia Cancer Specialists - Fairfax /ID# 231575 Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| START Midwest /ID# 231551 Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada /ID# 242930 Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Oncology Consultants /ID# 267347 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson Cancer Center at Texas Medical Center /ID# 248656 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Carolina BioOncology Institute /ID# 231541 Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Community Health Network, Inc. /ID# 245331 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Indiana University Melvin and Bren Simon Cancer Center /ID# 245133 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of California, Los Angeles /ID# 243841 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Yale School of Medicine /ID# 248418 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NEXT Oncology /ID# 231578 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Northwest Medical Specialties Tacoma /ID# 267339 Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.