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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05029882
Other study ID # M21-404
Secondary ID 2023-509335-60-0
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 13, 2021
Est. completion date November 23, 2025

Study information

Verified date June 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date November 23, 2025
Est. primary completion date November 23, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
ABBV-400
Intravenous (IV) Infusion
Trifluridine/Tipiracil
Oral Tablet
Bevacizumab
IV Infusion

Locations

Country Name City State
Australia Austin Health /ID# 247667 Heidelberg Victoria
Australia Mater Misericordiae Limited /ID# 249995 South Brisbane Queensland
France Institut Bergonie /ID# 248028 Bordeaux Gironde
France Centre Georges François Leclerc /ID# 244450 Dijon
France Centre Leon Berard /ID# 250987 Lyon CEDEX 08 Rhone
France Centre Antoine Lacassagne - Nice /ID# 231730 Nice Alpes-Maritimes
France AP-HP - Hopital Européen Georges Pompidou /ID# 250481 Paris
France CHU Nantes - Hopital Laennec /ID# 244723 Saint-Herblain
France Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399 St Herblain CEDEX Loire-Atlantique
France Institut Gustave Roussy /ID# 246824 Villejuif Cedex Val-de-Marne
Israel Rabin Medical Center /ID# 243363 Haifa
Israel Rambam Health Care Campus /ID# 231218 Haifa H_efa
Israel Hadassah Medical Center /ID# 243821 Jerusalem Yerushalayim
Israel Meir Medical Center /ID# 244179 Kfar Saba HaMerkaz
Israel The Chaim Sheba Medical Center /ID# 231217 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 245271 Tel Aviv Tel-Aviv
Japan National Cancer Center Hospital /ID# 232007 Chuo-ku Tokyo
Japan National Cancer Center Hospital East /ID# 232008 Kashiwa-shi Chiba
Japan The Cancer Institute Hospital Of JFCR /ID# 248447 Koto Tokyo
Japan Kyoto University Hospital /ID# 250291 Kyoto-shi Kyoto
Japan Nagasaki University Hospital /ID# 250290 Nagasaki-shi Nagasaki
Japan Aichi Cancer Center Hospital /ID# 250284 Nagoya-shi Aichi
Japan NHO Nagoya Medical Center /ID# 250286 Nagoya-shi Aichi
Japan Niigata University Medical & Dental Hospital /ID# 250952 Niigata-shi Niigata
Japan Wakayama Medical University Hospital /ID# 250283 Wakayama-shi Wakayama
Japan Yokohama Municipal Citizen's Hospital /ID# 248842 Yokohama-shi Kanagawa
Korea, Republic of Inje University Haeundae Hospital /ID# 244451 Busan
Korea, Republic of Chungbuk National University Hospital /ID# 245168 Cheongju Chungcheongbugdo
Korea, Republic of Gyeongsang National University Hospital /ID# 248420 Jinju Gyeongsangnamdo
Korea, Republic of CHA Bundang Medical Center /ID# 247115 Seongnam Gyeonggido
Korea, Republic of Asan Medical Center /ID# 245215 Seoul Seoul Teugbyeolsi
Korea, Republic of Kangbuk Samsung Hospital /ID# 248401 Seoul Seoul Teugbyeolsi
Korea, Republic of Korea University Guro Hospital /ID# 244504 Seoul Seoul Teugbyeolsi
Korea, Republic of Seoul National University Hospital /ID# 244667 Seoul
Korea, Republic of SMG-SNU Boramae Medical Center /ID# 248421 Seoul
Korea, Republic of Yonsei University Health System Severance Hospital /ID# 245218 Seoul Seoul Teugbyeolsi
Poland Samodzielny Publiczny Zespó? Gru?licy i Chorób P?uc w Olsztynie /ID# 250466 Olsztyn
Poland Med Polonia Sp. z o. o. /ID# 250799 Poznan Wielkopolskie
Poland Wojewodzki Szpital im. Sw. Ojca Pio /ID# 251846 Przemysl Podkarpackie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 246569 Warsaw Mazowieckie
Puerto Rico Pan American Center for Oncology Trials, LLC /ID# 231580 Rio Piedras
Spain Hospital Universitario Fundacion Alcorcon /ID# 244505 Alcorcon Madrid
Spain Instituto Catalan de Oncologia (ICO) Badalona /ID# 245379 Badalona Barcelona
Spain Hospital Clinic de Barcelona /ID# 245374 Barcelona
Spain Hospital Universitario Vall d'Hebron /ID# 249809 Barcelona
Spain Hospital Universitario de Jaen /ID# 249201 Jaen
Spain Hospital General Universitario Gregorio Maranon /ID# 245270 Madrid
Spain Hospital Universitario 12 de Octubre /ID# 248417 Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz /ID# 231464 Madrid
Spain Hospital Universitario HM Sanchinarro /ID# 244721 Madrid
Spain Clinica Universidad de Navarra - Pamplona /ID# 248816 Pamplona Navarra
Spain Hospital Clínico Universitario de Santiago-CHUS /ID# 245378 Santiago de Compostela A Coruna
Spain Hospital Universitario Virgen Macarena /ID# 245213 Sevilla
Spain Hospital Universitario Miguel Servet /ID# 244456 Zaragoza
Taiwan Changhua Christian Hospital /ID# 249150 Changhua City, Changhua County
Taiwan Cmuh /Id# 245729 Taichung
Taiwan National Cheng Kung University Hospital /ID# 245918 Tainan
Taiwan Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917 Taipei
Taiwan Taipei Veterans General Hosp /ID# 250652 Taipei
Taiwan National Taiwan University Hospital /ID# 245731 Taipei City Taipei
Taiwan Taipei Medical University Hospital /ID# 245732 Taipei City
Taiwan Tri-Service General Hospital /ID# 245733 Taipei City
Taiwan Linkou Chang Gung Memorial Hospital /ID# 248716 Taoyuan City
United States University Of Colorado Denver /ID# 231574 Aurora Colorado
United States Gabrail Cancer Center Research /ID# 248419 Canton Ohio
United States University of Illinois at Chicago /ID# 251386 Chicago Illinois
United States Duke Cancer Center /ID# 247236 Durham North Carolina
United States Virginia Cancer Specialists - Fairfax /ID# 231575 Fairfax Virginia
United States START Midwest /ID# 231551 Grand Rapids Michigan
United States Comprehensive Cancer Centers of Nevada /ID# 242930 Henderson Louisiana
United States MD Anderson Cancer Center at Texas Medical Center /ID# 248656 Houston Texas
United States Carolina BioOncology Institute /ID# 231541 Huntersville North Carolina
United States Community Health Network, Inc. /ID# 245331 Indianapolis Indiana
United States Indiana University Melvin and Bren Simon Cancer Center /ID# 245133 Indianapolis Indiana
United States University of California, Los Angeles /ID# 243841 Los Angeles California
United States Yale School of Medicine /ID# 248418 New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668 New York New York
United States NEXT Oncology /ID# 231578 San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  France,  Israel,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Up to Month 24
Secondary Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier. Up to 24 Months
Secondary PFS per RECIST v1.1 Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier. Up to 24 Months
Secondary Overall survival (OS) Overall survival (OS) is defined as time from first study treatment to death due to any cause. Up to 24 Months
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