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A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
Sponsor: AbbVie
Summary
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years. 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.
Official title: A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
390
Start Date
2025-04-24
Completion Date
2028-04
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Fluorouracil
IV Infusion; IV Injection
Oxaliplatin
IV Infusion
Leucovorin
IV Infusion; IV Injection
Bevacizumab
IV Infusion
Panitumumab
IV Infusion
Locations (43)
City of Hope National Medical Center /ID# 270255
Duarte, California, United States
Yale New Haven Hospital /ID# 270565
New Haven, Connecticut, United States
Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois, United States
Dana-Farber Cancer Institute /ID# 270624
Boston, Massachusetts, United States
Saint Lukes Hospital of Kansas City /ID# 270633
Kansas City, Missouri, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska, United States
University of North Carolina Medical Center /ID# 267786
Chapel Hill, North Carolina, United States
Oncology Hematology Care - Eastgate /ID# 271493
Cincinnati, Ohio, United States
Texas Oncology - Austin Midtown /ID# 271354
Austin, Texas, United States
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Webster, Texas, United States
Macquarie University /ID# 271514
Sydney, New South Wales, Australia
Mater Hospital Brisbane /ID# 270694
South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital /ID# 270693
Woodville, South Australia, Australia
Austin Health /ID# 270692
Heidelberg, Victoria, Australia
One Clinical Research /ID# 270695
Nedlands, Western Australia, Australia
Medizinische Universitaet Wien /ID# 268872
Vienna, Austria
ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 270147
Ijuí, Rio Grande do Sul, Brazil
Fakultní nemocnice Hradec Králové - Sokolská /ID# 268773
Hradec Králové, Hradec Kralove, Czechia
Fakultni Thomayerova nemocnice /ID# 269632
Prague, Praha, Hlavni Mesto, Czechia
Chu De Lille - Hopital Claude Huriez /ID# 270222
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Poitiers /ID# 270225
Poitiers, Nouvelle-Aquitaine, France
Hôpital Européen Georges Pompidou /ID# 270224
Paris, France
St. Luke's Hospital S.A. /ID# 269963
Panórama, Thessaloniki, Greece
Theagenio Cancer Hospital /ID# 269640
Thessaloniki, Greece
Tel Aviv Sourasky Medical Center /ID# 268010
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 268006
Haifa, Israel
Shaare Zedek Medical Center /ID# 268009
Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 268007
Jerusalem, Israel
Rabin Medical Center. /ID# 268008
Petah Tikva, Israel
Aichi Cancer Center /ID# 270113
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 270114
Kashiwa-shi, Chiba, Japan
St Marianna University School Of Medicine /ID# 270111
Kawasaki-shi, Kanagawa, Japan
Tohoku University Hospital /ID# 270966
Sendai, Miyagi, Japan
National Cancer Center Hospital /ID# 270112
Chuo-Ku, Tokyo, Japan
Pan American Center for Oncology Trials /ID# 268809
Rio Piedras, Puerto Rico
Hospital Universitario Marques de Valdecilla /ID# 269732
Santander, Cantabria, Spain
Hospital Universitario Vall de Hebron /ID# 270191
Barcelona, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 269726
Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724
Kaohsiung City, Taiwan
National Cheng Kung University Hospital /ID# 270835
Tainan, Taiwan
National Taiwan University Hospital /ID# 269717
Taipei, Taiwan
Taipei Veterans General Hospital- Taipei City /ID# 269718
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 269725
Taoyuan, Taiwan