Actively Recruiting
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
Led by AbbVie · Updated on 2026-04-15
390
Participants Needed
44
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Laboratory values meeting the protocol criteria
- Measurable metastatic colorectal cancer according to RECIST v1.1
You will not qualify if you...
- Previous treatment with c-Met targeting agents or topoisomerase inhibitors such as irinotecan
- History of other cancers within 5 years before screening, except those with negligible risk of metastasis or death
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
City of Hope National Medical Center /ID# 270255
Duarte, California, United States, 91010
Actively Recruiting
2
Yale New Haven Hospital /ID# 270565
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois, United States, 60521
Actively Recruiting
4
Dana-Farber Cancer Institute /ID# 270624
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Saint Lukes Hospital of Kansas City /ID# 270633
Kansas City, Missouri, United States, 64111
Actively Recruiting
6
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska, United States, 68130
Actively Recruiting
7
University of North Carolina Medical Center /ID# 267786
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
8
Oncology Hematology Care - Eastgate /ID# 271493
Cincinnati, Ohio, United States, 45245
Actively Recruiting
9
Texas Oncology - Austin Midtown /ID# 271354
Austin, Texas, United States, 78705
Actively Recruiting
10
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Webster, Texas, United States, 77598
Actively Recruiting
11
Macquarie University /ID# 271514
Sydney, New South Wales, Australia, 2109
Actively Recruiting
12
Mater Hospital Brisbane /ID# 270694
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
13
The Queen Elizabeth Hospital /ID# 270693
Woodville, South Australia, Australia, 5011
Actively Recruiting
14
Austin Health /ID# 270692
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
15
One Clinical Research /ID# 270695
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
16
Medizinische Universitaet Wien /ID# 268872
Vienna, Austria, 1090
Actively Recruiting
17
ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 270147
Ijuí, Rio Grande do Sul, Brazil, 98700-000
Actively Recruiting
18
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
19
Fakultní nemocnice Hradec Králové - Sokolská /ID# 268773
Hradec Králové, Hradec Kralove, Czechia, 500 05
Actively Recruiting
20
Fakultni Thomayerova nemocnice /ID# 269632
Prague, Praha, Hlavni Mesto, Czechia, 140 59
Actively Recruiting
21
Chu De Lille - Hopital Claude Huriez /ID# 270222
Lille, Hauts-de-France, France, 59037
Actively Recruiting
22
Centre Hospitalier Universitaire de Poitiers /ID# 270225
Poitiers, New Aquitaine, France, 86021
Actively Recruiting
23
Hôpital Européen Georges Pompidou /ID# 270224
Paris, France, 75015
Actively Recruiting
24
St. Luke's Hospital S.A. /ID# 269963
Panórama, Thessaloniki, Greece, 55236
Actively Recruiting
25
Theagenio Cancer Hospital /ID# 269640
Thessaloniki, Greece, 54639
Actively Recruiting
26
Tel Aviv Sourasky Medical Center /ID# 268010
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
27
Rambam Health Care Campus- Haifa /ID# 268006
Haifa, Israel, 3525408
Actively Recruiting
28
Shaare Zedek Medical Center /ID# 268009
Jerusalem, Israel, 9103102
Actively Recruiting
29
Hadassah Medical Center-Hebrew University /ID# 268007
Jerusalem, Israel, 91120
Actively Recruiting
30
Rabin Medical Center. /ID# 268008
Petah Tikva, Israel, 4941492
Actively Recruiting
31
Aichi Cancer Center /ID# 270113
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
32
National Cancer Center Hospital East /ID# 270114
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
33
St Marianna University School Of Medicine /ID# 270111
Kawasaki-shi, Kanagawa, Japan, 216-8511
Actively Recruiting
34
Tohoku University Hospital /ID# 270966
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
35
National Cancer Center Hospital /ID# 270112
Chuo-Ku, Tokyo, Japan, 104-0045
Actively Recruiting
36
Pan American Center for Oncology Trials /ID# 268809
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
37
Hospital Universitario Marques de Valdecilla /ID# 269732
Santander, Cantabria, Spain, 39008
Actively Recruiting
38
Hospital Universitario Vall de Hebron /ID# 270191
Barcelona, Spain, 08035
Actively Recruiting
39
Kaohsiung Chang Gung Memorial Hospital /ID# 269726
Kaohsiung City, Kaohsiung, Taiwan, 833
Actively Recruiting
40
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724
Kaohsiung City, Taiwan, 807
Actively Recruiting
41
National Cheng Kung University Hospital /ID# 270835
Tainan, Taiwan, 704
Actively Recruiting
42
National Taiwan University Hospital /ID# 269717
Taipei, Taiwan, 100
Actively Recruiting
43
Taipei Veterans General Hospital /ID# 269718
Taipei, Taiwan, 112
Actively Recruiting
44
Linkou Chang Gung Memorial Hospital /ID# 269725
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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