Phase
Condition
Colorectal Cancer
Colon Cancer
Rectal Cancer
Treatment
ABBV-400
Trifluridine/Tipiracil
Bevacizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-smallcell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC),gastroesophagel junction adenocarcinoma (GEA), colorectal cancer (CRC), and renalcell carcinoma (RCC), who have progressed on all standard of care therapy and arenot amenable to surgical resection or other approved therapeutic options that havedemonstrated 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/orappropriate 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 excludingadjuvant therapy and must have advanced NSCLC that is not amenable to surgicalresection or other approved therapeutic options that have demonstrated clinicalbenefit.
For Part 3 only - Participants with advanced GEA that has progressed after treatmentwith at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced ormetastatic disease and have not received more than 2 prior lines of cytotoxicchemotherapy regimens. Participants must have progressed on
If applicable, an immune checkpoint inhibitor.
If applicable, appropriate available therapies, including HER2-directedtherapies.
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 orcytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600Emutation 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 orpanitumumab).
If applicable, anti-vascular endothelial growth factor (VEGF) monoclonalantibody (including but not limited to bevacizumab, ramucirumab, oraflibercept).
If applicable, targeted therapy
Participants who are considered ineligible for or are intolerant of standardtherapy per investigator are eligible. Prior trifluridine/tipiracil (TAS-102)or Regorafenib treated participants are eligible.
For Part 5 only - participants with advanced histologically or cytologicallyconfirmed solid tumors characterized by MET amplification who are not amenable tosurgical resection and who have disease progression after at least one priorsystemic 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 advancedhistopathologically or cytologically confirmed CRC that does not harbor the mutationand 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 orpanitumumab)
If applicable, anti-vascular endothelial growth factor (VEGF) monoclonalantibody (including but not limited to bevacizumab, ramucirumab, oraflibercept)
If applicable, targeted therapy Participants who are considered ineligible foror 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
Exclusion Criteria:
History of interstitial lung disease (ILD) or pneumonitis that required treatmentwith systemic steroids, nor any evidence of active ILD or on screening chest CTscan..
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitisobliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
History of clinically significant, intercurrent lung-specific illnesses, as noted inthe protocol.
For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.
Study Design
Connect with a study center
Mater Misericordiae Limited /ID# 249995
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Austin Health /ID# 247667
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Centre Antoine Lacassagne - Nice /ID# 231730
Nice, Alpes-Maritimes 06189
FranceActive - Recruiting
Centre Antoine Lacassagne - Nice/ ID# 231730
Nice, Alpes-Maritimes 06189
FranceActive - Recruiting
Institut Bergonie /ID# 248028
Bordeaux, Gironde 33000
FranceActive - Recruiting
Institut Curie /ID# 231597
Paris CEDEX 05, Ile-de-France 75248
FranceSite Not Available
CHU Nantes - Hopital Laennec /ID# 244723
Saint-Herblain, Loire-Atlantique 44800
FranceActive - Recruiting
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399
St Herblain CEDEX, Loire-Atlantique 44805
FranceActive - Recruiting
CHU de Nantes, Hotel Dieu -HME / ID# 245266
Nantes, Pays-de-la-Loire 44000
FranceSite Not Available
Centre Antoine-Lacassagne /ID# 231730
Nice, Provence-Alpes-Cote-d Azur 06189
FranceActive - Recruiting
Centre Leon Berard /ID# 250987
Lyon CEDEX 08, Rhone 69373
FranceActive - Recruiting
Institut Gustave Roussy /ID# 246824
Villejuif Cedex, Val-de-Marne 94805
FranceActive - Recruiting
Institut Bergonie/ID# 248028
Bordeaux, 33000
FranceActive - Recruiting
Centre Georges François Leclerc /ID# 244450
Dijon, 21079
FranceActive - Recruiting
Centre Georges François Leclerc/ID# 244450
Dijon, 21079
FranceActive - Recruiting
AP-HP - Hopital Européen Georges Pompidou /ID# 250481
Paris, 75015
FranceActive - Recruiting
AP-HP - Hopital Européen Georges Pompidou/ID# 250481
Paris, 75015
FranceActive - Recruiting
Rambam Health Care Campus /ID# 231218
Haifa, H_efa 3109601
IsraelActive - Recruiting
Meir Medical Center /ID# 244179
Kfar Saba, HaMerkaz 4428164
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 231217
Ramat Gan, Tel-Aviv 5265601
IsraelCompleted
Tel Aviv Sourasky Medical Center /ID# 245271
Tel Aviv, Tel-Aviv 6423906
IsraelActive - Recruiting
Hadassah Medical Center /ID# 243821
Jerusalem, Yerushalayim 91120
IsraelActive - Recruiting
Rabin Medical Center /ID# 243363
Haifa, 4941492
IsraelActive - Recruiting
Meir Medical Center /ID# 244179
Kfar Sava, 4428164
IsraelSite Not Available
Rabin Medical Center /ID# 243363
Peta Tikva, 4941492
IsraelSite Not Available
Rabin Medical Center /ID# 243363
Petah Tikva, 4941492
IsraelSite Not Available
Aichi Cancer Center Hospital /ID# 250284
Nagoya-shi, Aichi 464-8681
JapanActive - Recruiting
NHO Nagoya Medical Center /ID# 250286
Nagoya-shi, Aichi 460-0001
JapanActive - Recruiting
National Cancer Center Hospital East /ID# 232008
Kashiwa-shi, Chiba 277-8577
JapanActive - Recruiting
Yokohama Municipal Citizen's Hospital /ID# 248842
Yokohama-shi, Kanagawa 221-0855
JapanActive - Recruiting
Kyoto University Hospital /ID# 250291
Kyoto-shi, Kyoto 606-8507
JapanActive - Recruiting
Nagasaki University Hospital /ID# 250290
Nagasaki-shi, Nagasaki 852-8501
JapanActive - Recruiting
Niigata University Medical & Dental Hospital /ID# 250952
Niigata-shi, Niigata 951-8520
JapanActive - Recruiting
National Cancer Center Hospital /ID# 232007
Chuo-ku, Tokyo 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital Of JFCR /ID# 248447
Koto, Tokyo 135-8550
JapanSite Not Available
The Cancer Institute Hospital Of JFCR /ID# 248447
Koto-ku, Tokyo 135-8550
JapanActive - Recruiting
Wakayama Medical University Hospital /ID# 250283
Wakayama-shi, Wakayama 641-8510
JapanSite Not Available
The Cancer Institute Hospital Of JFCR / ID#248447
Koto,
JapanSite Not Available
Kyoto University Hospital /ID#250291
Kyoto, 606-8507
JapanSite Not Available
Nagasaki University Hospital /ID# 250290
Nagasaki, 852-8501
JapanSite Not Available
Aichi Cancer Center Hospital /ID#250284
Nagoya, 464-8681
JapanSite Not Available
NHO Nagoya Medical Center /ID# 250286
Nagoya, 460-0001
JapanActive - Recruiting
Niigata University Medical & Dental Hospital /ID# 250952
Niigata, 951-8520
JapanSite Not Available
Wakayama Medical University Hospital /ID# 250283
Wakayama, 641-0012
JapanActive - Recruiting
Yokohama Municipal Citizen's Hospital/ID# 248842
Yokohama, 221-0855
JapanSite Not Available
Inje University Haeundae Hospital /ID# 244451
Busan, Busan Gwang Yeogsi 48108
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital /ID# 245168
Cheongju, Chungcheongbugdo 28644
Korea, Republic ofActive - Recruiting
CHA Bundang Medical Center /ID# 247115
Seongnam, Gyeonggido 13496
Korea, Republic ofActive - Recruiting
CHA University Bundang Medical Center/ID# 247115
Seongnam, Gyeonggido 13496
Korea, Republic ofSite Not Available
CHA University Bundang Medical Center /ID# 247115
Seongnam si, Gyeonggido 13496
Korea, Republic ofSite Not Available
CHA Bundang Medical Center /ID# 247115
성남시, Gyeonggido 13496
Korea, Republic ofSite Not Available
Gyeongsang National University Hospital / ID# 248420
Jinju, Gyeongsangnamdo 52727
Korea, Republic ofActive - Recruiting
Gyeongsang National University Hospital /ID# 248420
Jinju, Gyeongsangnamdo 52727
Korea, Republic ofActive - Recruiting
Asan Medical Center /ID# 245215
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofActive - Recruiting
Kangbuk Samsung Hospital /ID# 248401
Seoul, Seoul Teugbyeolsi 03181
Korea, Republic ofActive - Recruiting
Kangbuk Samsung Hospital/ID# 248401
Seoul, Seoul Teugbyeolsi 03181
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital /ID# 244504
Seoul, Seoul Teugbyeolsi 08308
Korea, Republic ofActive - Recruiting
SMG-SNU Boramae Medical Center /ID# 248421
Seoul, Seoul Teugbyeolsi 07061
Korea, Republic ofActive - Recruiting
SMG-SNU Boramae Medical Center /ID#248421
Seoul, Seoul Teugbyeolsi 07061
Korea, Republic ofActive - Recruiting
Seoul National University Hospital /ID# 244667
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofActive - Recruiting
Yonsei University Health System Severance Hospital/ID# 245218
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Inje University Haeundae Hospital / ID# 244451
Busan, 48108
Korea, Republic ofActive - Recruiting
Chungbuk National Univ Hosp /ID# 245168
Cheongju, 28644
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital / ID# 244452
Cheongju, 28644
Korea, Republic ofActive - Recruiting
Asan Medical Center / ID# 245215
Seoul, 05505
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital /ID#244504
Seoul, 08308
Korea, Republic ofActive - Recruiting
Seoul National University Hospital / ID# 244667
Seoul, 03080
Korea, Republic ofActive - Recruiting
Yonsei University Health System Severance Hospital /ID# 245218
Seoul, 03722
Korea, Republic ofActive - Recruiting
SMG-SNU Boramae Medical Center /ID# 248421
동작구, 07061
Korea, Republic ofSite Not Available
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 246569
Warsaw, Mazowieckie 02-781
PolandActive - Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio /ID# 251846
Przemysl, Podkarpackie 37-700
PolandActive - Recruiting
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu /ID# 251846
Przemysl, Podkarpackie 37-700
PolandActive - Recruiting
Med Polonia Sp. z o. o. /ID# 250799
Poznan, Wielkopolskie 60-693
PolandActive - Recruiting
Samodzielny Publiczny Zespó? Gru?licy i Chorób P?uc w Olsztynie /ID# 250466
Olsztyn, 10-357
PolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 250466
Olsztyn, 10-357
PolandActive - Recruiting
Pan American Center for Oncology Trials, LLC /ID# 231580
Rio Piedras, 00935
Puerto RicoActive - Recruiting
Hospital Clínico Universitario de Santiago-CHUS /ID# 245378
Santiago de Compostela, A Coruna 15706
SpainActive - Recruiting
Instituto Catalan de Oncologia (ICO) Badalona /ID# 245379
Badalona, Barcelona 08916
SpainActive - Recruiting
Hospital Universitario de Jaen /ID# 249201
Jaén, Jaen 23007
SpainSite Not Available
Hospital Universitario Fundacion Alcorcon /ID# 244505
Alcorcon, Madrid 28922
SpainActive - Recruiting
Hospital Universitario Fundacion Alcorcon /ID# 244505
Alcorcón, Madrid 28922
SpainSite Not Available
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 248816
Pamplona, Navarra 31008
SpainActive - Recruiting
Clinica Universidad de Navarra - Pamplona /ID# 248816
Pamplona, Navarra 31008
SpainActive - Recruiting
Hospital Universitario Virgen Macarena /ID# 245213
Seville, Sevilla 41009
SpainSite Not Available
Hospital Clinic de Barcelona /ID# 245374
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron /ID# 249809
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario de Jaen /ID# 249201
Jaen, 23007
SpainActive - Recruiting
Hospital General Universitario Gregorio Maranon /ID# 245270
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 248417
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 231464
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro /ID# 244721
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Virgen Macarena /ID# 245213
Sevilla, 41009
SpainActive - Recruiting
Hospital Universitario Miguel Servet /ID# 244456
Zaragoza, 50009
SpainActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital /ID# 246449
Kaohsiung City, Kaohsiung 833
TaiwanActive - Recruiting
National Taiwan University Hospital /ID# 245731
Taipei City, Taipei 100
TaiwanActive - Recruiting
Changhua Christian Hospital /ID# 249150
Changhua City, Changhua County, 50006
TaiwanActive - Recruiting
Cmuh /Id# 245729
Taichung, 40701
TaiwanActive - Recruiting
Cmuh /Id#245729
Taichung, 40701
TaiwanActive - Recruiting
National Cheng Kung University Hospital /ID# 245918
Tainan, 704
TaiwanActive - Recruiting
Koo Foundation Sun Yat-Sen Cancer Center /ID# 245917
Taipei, 112
TaiwanActive - Recruiting
Taipei Medical University Hospital /ID# 245732
Taipei, 11031
TaiwanActive - Recruiting
Taipei Veterans General Hosp /ID# 250652
Taipei, 11217
TaiwanActive - Recruiting
Tri-Service General Hospital /ID# 245733
Taipei, 114
TaiwanActive - Recruiting
Taipei Medical University Hospital /ID# 245732
Taipei City, 11031
TaiwanActive - Recruiting
Taipei Veterans General Hospital /ID# 250652
Taipei City, 11217
TaiwanActive - Recruiting
Tri-Service General Hospital /ID# 245733
Taipei City, 11490
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital /ID# 248716
Taoyuan City, 333
TaiwanActive - Recruiting
University of California, Los Angeles /ID# 243841
Los Angeles, California 90095
United StatesActive - Recruiting
University of California, Los Angeles /ID# 243841
Santa Monica, California 90404-2125
United StatesSite Not Available
University of California, Los Angeles/ID# 243841
Santa Monica, California 90404-2125
United StatesSite Not Available
Univ of Colorado Cancer Center /ID# 231574
Aurora, Colorado 80045
United StatesActive - Recruiting
University Of Colorado Denver /ID# 231574
Aurora, Colorado 80045-2530
United StatesActive - Recruiting
Yale School of Medicine /ID# 248418
New Haven, Connecticut 06519
United StatesActive - Recruiting
Yale School of Medicine/ID# 248418
New Haven, Connecticut 06519
United StatesActive - Recruiting
University of Illinois at Chicago /ID# 251386
Chicago, Illinois 60607
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology - Fort Wayne - East Dupont Road /ID# 267338
Fort Wayne, Indiana 46825
United StatesActive - Recruiting
Community Health Network, Inc. /ID# 245331
Indianapolis, Indiana 46250-2042
United StatesActive - Recruiting
Indiana University Melvin and Bren Simon Cancer Center /ID# 245133
Indianapolis, Indiana 46202-5112
United StatesCompleted
Indiana University Melvin and Bren Simon Cancer Center/ID# 245133
Indianapolis, Indiana 46202-5112
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada /ID# 242930
Henderson, Louisiana 89052
United StatesActive - Recruiting
START Midwest /ID# 231551
Grand Rapids, Michigan 49546-7062
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada /ID# 242930
Las Vegas, Nevada 89119
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 250668
New York, New York 10065-6007
United StatesActive - Recruiting
Duke Cancer Center / ID# 247236
Durham, North Carolina 27710-3000
United StatesActive - Recruiting
Duke Cancer Center /ID# 247236
Durham, North Carolina 27710-3000
United StatesActive - Recruiting
Carolina BioOncology Institute /ID# 231541
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Gabrail Cancer Center Research /ID# 248419
Canton, Ohio 44718
United StatesCompleted
MD Anderson Cancer Center at Texas Medical Center /ID# 248656
Houston, Texas 77030-4000
United StatesActive - Recruiting
MD Anderson Cancer Center at Texas Medical Center/ID# 248656
Houston, Texas 77030-4000
United StatesActive - Recruiting
Oncology Consultants /ID# 267347
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology /ID# 231578
San Antonio, Texas 78229
United StatesActive - Recruiting
Virginia Cancer Specialists - Fairfax /ID# 231575
Fairfax, Virginia 22031
United StatesActive - Recruiting
Northwest Medical Specialties Tacoma /ID# 267339
Tacoma, Washington 98405
United StatesActive - Recruiting
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