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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

NCT06820463 · AbbVie
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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Laboratory values meeting the criteria within the protocol. * Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1. Exclusion Criteria: * Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan). * History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.
Study design
Enrollment target: 390 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-24
Estimated completion: 2028-04
Last updated: 2026-04-15
Interventions
Drug: Telisotuzumab AdizutecanDrug: FluorouracilDrug: OxaliplatinDrug: LeucovorinDrug: BevacizumabDrug: Panitumumab
Primary outcomes
  • Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1. (Up to 24 Weeks)
  • Number of Participants with Adverse Events (AE)s (Up to Approximately 6 Years)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (44)
City of Hope National Medical Center /ID# 270255Recruiting
Duarte, California, United States
Yale New Haven Hospital /ID# 270565Recruiting
New Haven, Connecticut, United States
Hope And Healing Cancer Services /ID# 271562Recruiting
Hinsdale, Illinois, United States
Dana-Farber Cancer Institute /ID# 270624Recruiting
Boston, Massachusetts, United States
Saint Lukes Hospital of Kansas City /ID# 270633Recruiting
Kansas City, Missouri, United States
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646Recruiting
Omaha, Nebraska, United States
University of North Carolina Medical Center /ID# 267786Recruiting
Chapel Hill, North Carolina, United States
Oncology Hematology Care - Eastgate /ID# 271493Recruiting
Cincinnati, Ohio, United States
Texas Oncology - Austin Midtown /ID# 271354Recruiting
Austin, Texas, United States
Texas Oncology - Deke Slayton Cancer Center /ID# 271355Recruiting
Webster, Texas, United States
Macquarie University /ID# 271514Recruiting
Sydney, New South Wales, Australia
Mater Hospital Brisbane /ID# 270694Recruiting
South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital /ID# 270693Recruiting
Woodville, South Australia, Australia
Austin Health /ID# 270692Recruiting
Heidelberg, Victoria, Australia
One Clinical Research /ID# 270695Recruiting
Nedlands, Western Australia, Australia
Medizinische Universitaet Wien /ID# 268872Recruiting
Vienna, Austria
ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 270147Recruiting
Ijuí, Rio Grande do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651Recruiting
São José do Rio Preto, São Paulo, Brazil
Fakultní nemocnice Hradec Králové - Sokolská /ID# 268773Recruiting
Hradec Králové, Hradec Kralove, Czechia
Fakultni Thomayerova nemocnice /ID# 269632Recruiting
Prague, Praha, Hlavni Mesto, Czechia
Chu De Lille - Hopital Claude Huriez /ID# 270222Recruiting
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Poitiers /ID# 270225Recruiting
Poitiers, New Aquitaine, France
Hôpital Européen Georges Pompidou /ID# 270224Recruiting
Paris, France
St. Luke's Hospital S.A. /ID# 269963Recruiting
Panórama, Thessaloniki, Greece
Theagenio Cancer Hospital /ID# 269640Recruiting
Thessaloniki, Greece
Tel Aviv Sourasky Medical Center /ID# 268010Recruiting
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 268006Recruiting
Haifa, Israel
Shaare Zedek Medical Center /ID# 268009Recruiting
Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 268007Recruiting
Jerusalem, Israel
Rabin Medical Center. /ID# 268008Recruiting
Petah Tikva, Israel
Aichi Cancer Center /ID# 270113Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East /ID# 270114Recruiting
Kashiwa-shi, Chiba, Japan
St Marianna University School Of Medicine /ID# 270111Recruiting
Kawasaki-shi, Kanagawa, Japan
Tohoku University Hospital /ID# 270966Recruiting
Sendai, Miyagi, Japan
National Cancer Center Hospital /ID# 270112Recruiting
Chuo-Ku, Tokyo, Japan
Pan American Center for Oncology Trials /ID# 268809Recruiting
Rio Piedras, Puerto Rico
Hospital Universitario Marques de Valdecilla /ID# 269732Recruiting
Santander, Cantabria, Spain
Hospital Universitario Vall de Hebron /ID# 270191Recruiting
Barcelona, Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 269726Recruiting
Kaohsiung City, Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724Recruiting
Kaohsiung City, Taiwan
National Cheng Kung University Hospital /ID# 270835Recruiting
Tainan, Taiwan
National Taiwan University Hospital /ID# 269717Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital /ID# 269718Recruiting
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 269725Recruiting
Taoyuan, Taiwan
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 · TrialPath