NCT06820463From ClinicalTrials.govRecruiting

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

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

Metastatic Colorectal Cancer

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AbbVie
Enrolment target: 390
Started: 24 April 2025
Main results due: March 2028
Study sites: 75
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(75)

City of Hope National Medical Center /ID# 270255
Duarte, California, United States
Recruiting
UCLA - Santa Monica /ID# 270621
Santa Monica, California, United States
Recruiting
Yale New Haven Hospital /ID# 270565
New Haven, Connecticut, United States
Recruiting
AdventHealth Orlando /ID# 270789
Orlando, Florida, United States
Recruiting
Northwest Georgia Oncology Centers /ID# 270245
Marietta, Georgia, United States
Recruiting
University of Chicago Medical Center /ID# 271688
Chicago, Illinois, United States
Recruiting
Hope And Healing Cancer Services /ID# 271562
Hinsdale, Illinois, United States
Recruiting
Dana-Farber Cancer Institute /ID# 270624
Boston, Massachusetts, United States
Recruiting
University Of Michigan /ID# 270790
Ann Arbor, Michigan, United States
Recruiting
Saint Lukes Hospital of Kansas City /ID# 270633
Kansas City, Missouri, United States
Recruiting
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646
Omaha, Nebraska, United States
Recruiting
University of North Carolina Medical Center /ID# 267786
Chapel Hill, North Carolina, United States
Recruiting
Oncology Hematology Care - Eastgate /ID# 271493
Cincinnati, Ohio, United States
Recruiting
Texas Oncology - Austin Midtown /ID# 271354
Austin, Texas, United States
Recruiting
Texas Oncology - Deke Slayton Cancer Center /ID# 271355
Webster, Texas, United States
Recruiting
Virginia Cancer Specialists - Fairfax /ID# 271351
Fairfax, Virginia, United States
Recruiting
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298
Seattle, Washington, United States
Recruiting
Macquarie University /ID# 271514
Sydney, New South Wales, Australia
Recruiting
Mater Misericordiae /ID# 270694
South Brisbane, Queensland, Australia
Recruiting
The Queen Elizabeth Hospital /ID# 270693
Woodville South, South Australia, Australia
Recruiting
Austin Health /ID# 270692
Heidelberg, Victoria, Australia
Recruiting
One Clinical Research /ID# 270695
Nedlands, Western Australia, Australia
Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 268874
Salzburg, Austria
Recruiting
Medizinische Universitaet Wien /ID# 268872
Vienna, Austria
Recruiting
Hospital Sao Rafael /ID# 271681
Salvador, Estado de Bahia, Brazil
Recruiting
Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147
Ijuí, Rio Grande do Sul, Brazil
Recruiting
Hospital De Amor /ID# 271874
Barretos, São Paulo, Brazil
Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651
São José do Rio Preto, São Paulo, Brazil
Recruiting
Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 270546
São Paulo, Brazil
Recruiting
Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311
São Paulo, Brazil
Recruiting
Arthur J.E Child Comprehensive Cancer Centre /ID# 269809
Calgary, Alberta, Canada
Recruiting
Cross Cancer Institute. /ID# 272711
Edmonton, Alberta, Canada
Recruiting
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270680
London, Ontario, Canada
Recruiting
Princess Margaret Cancer Centre /ID# 268715
Toronto, Ontario, Canada
Recruiting
Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 271368
Montreal, Quebec, Canada
Recruiting
Vseobecna Fakultni nemocnice v Praze /ID# 268775
Prague, Praha 17, Czechia
Recruiting
Fakultni nemocnice Motol a Homolka /ID# 268776
Prague, Praha 5, Czechia
Recruiting
Fakultni Thomayerova nemocnice /ID# 269632
Prague, Praha, Hlavni Mesto, Czechia
Recruiting
Masarykuv onkologicky ustav v Brne /ID# 268779
Brno, Czechia
Recruiting
Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773
Hradec Králové, Czechia
Recruiting
Chu De Lille - Hopital Claude Huriez /ID# 270222
Lille, Hauts-de-France, France
Recruiting
Centre Hospitalier Universitaire de Poitiers /ID# 270225
Poitiers, New Aquitaine, France
Recruiting
Hopital Europeen Georges Pompidou /ID# 270224
Paris, France
Recruiting
Hopital Pitie Salpetriere /ID# 270220
Paris, Île-de-France Region, France
Recruiting
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 268762
Nea Kifissia, Attica, Greece
Recruiting
St. Luke's Hospital /ID# 269963
Panórama, Thessaloniki, Greece
Recruiting
Theagenio Cancer Hospital /ID# 269640
Thessaloniki, Greece
Recruiting
Rabin Medical Center. /ID# 268008
Petah Tikva, Central District, Israel
Recruiting
Tel Aviv Sourasky Medical Center /ID# 268010
Tel Aviv, Tel Aviv, Israel
Recruiting
Rambam Health Care Campus- Haifa /ID# 268006
Haifa, Israel
Recruiting
Shaare Zedek Medical Center /ID# 268009
Jerusalem, Israel
Recruiting
Hadassah Medical Center-Hebrew University /ID# 268007
Jerusalem, Israel
Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 269191
Naples, Napoli, Italy
Recruiting
Aichi Cancer Center /ID# 270113
Nagoya, Aichi-ken, Japan
Recruiting
National Cancer Center Hospital East /ID# 270114
Kashiwa-shi, Chiba, Japan
Recruiting
St Marianna University School Of Medicine /ID# 270111
Kawasaki-shi, Kanagawa, Japan
Recruiting
Tohoku University Hospital /ID# 270966
Sendai, Miyagi, Japan
Recruiting
National Cancer Center Hospital /ID# 270112
Chuo-Ku, Tokyo, Japan
Recruiting
Pan American Center for Oncology Trials - Rio Piedras /ID# 268809
Rio Piedras, Puerto Rico
Recruiting
Puerto Rico Medical Research Center /ID# 268825
San Juan, Puerto Rico
Recruiting

Showing 60 of 75 sites — filter to narrow it down. 75 of the 75 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06820463. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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