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RECRUITING Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06820463

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Telisotuzumab Adizutecan (Drug)
    Intravenous (IV) Infusion
  • Fluorouracil (Drug)
    IV Infusion; IV Injection
  • Oxaliplatin (Drug)
    IV Infusion
  • Leucovorin (Drug)
    IV Infusion; IV Injection
  • Bevacizumab (Drug)
    IV Infusion
  • Panitumumab (Drug)
    IV Infusion

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.

Conditions

Metastatic Colorectal Cancer

Locations

  • City of Hope National Medical Center /ID# 270255 — Duarte, California, United States
  • UCLA - Santa Monica /ID# 270621 — Santa Monica, California, United States
  • Yale New Haven Hospital /ID# 270565 — New Haven, Connecticut, United States
  • AdventHealth Orlando /ID# 270789 — Orlando, Florida, United States
  • Northwest Georgia Oncology Centers /ID# 270245 — Marietta, Georgia, United States
  • University of Chicago Medical Center /ID# 271688 — Chicago, Illinois, United States
  • Hope And Healing Cancer Services /ID# 271562 — Hinsdale, Illinois, United States
  • Dana-Farber Cancer Institute /ID# 270624 — Boston, Massachusetts, United States
  • University Of Michigan /ID# 270790 — Ann Arbor, Michigan, 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 at Chapel Hill /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
  • Virginia Cancer Specialists - Fairfax /ID# 271351 — Fairfax, Virginia, United States
  • University Of Washington /ID# 271298 — Seattle, Washington, United States
  • Macquarie University /ID# 271514 — Sydney, New South Wales, Australia
  • Mater Misericordiae /ID# 270694 — South Brisbane, Queensland, Australia
  • The Queen Elizabeth Hospital /ID# 270693 — Woodville South, South Australia, Australia
  • Austin Health /ID# 270692 — Heidelberg, Victoria, Australia
  • One Clinical Research /ID# 270695 — Nedlands, Western Australia, Australia
  • Medizinische Universitaet Graz /ID# 268876 — Graz, Styria, Austria
  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 268874 — Salzburg, Austria
  • Medizinische Universitaet Wien /ID# 268872 — Vienna, Austria
  • Hospital Sao Rafael /ID# 271681 — Salvador, Estado de Bahia, Brazil
  • Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147 — Ijuí, Rio Grande do Sul, Brazil
  • Hospital De Amor /ID# 271874 — Barretos, São Paulo, Brazil
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651 — São José do Rio Preto, São Paulo, Brazil
  • Instituto D Or De Pesquisa E Ensino - Regional Sao Paulo /ID# 270546 — São Paulo, Brazil
  • Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311 — São Paulo, Brazil
  • Arthur J.E Child Comprehensive Cancer Centre /ID# 269809 — Calgary, Alberta, Canada
  • Cross Cancer Institute. /ID# 272711 — Edmonton, Alberta, Canada
  • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270680 — London, Ontario, Canada
  • Princess Margaret Cancer Centre /ID# 268715 — Toronto, Ontario, Canada
  • Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 271368 — Montreal, Quebec, Canada
  • Vseobecna Fakultni nemocnice v Praze /ID# 268775 — Prague, Praha 17, Czechia
  • Fakultni nemocnice Motol a Homolka /ID# 268776 — Prague, Praha 5, Czechia
  • Fakultni Thomayerova nemocnice /ID# 269632 — Prague, Praha, Hlavni Mesto, Czechia
  • Masarykuv onkologicky ustav v Brne /ID# 268779 — Brno, Czechia
  • Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773 — Hradec Králové, Czechia
  • Chu De Lille - Hopital Claude Huriez /ID# 270222 — Lille, Hauts-de-France, France
  • Centre Hospitalier Universitaire de Poitiers /ID# 270225 — Poitiers, New Aquitaine, France
  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 270221 — Nantes, Pays de la Loire Region, France
  • Hopital Europeen Georges Pompidou /ID# 270224 — Paris, France
  • Hopital Pitie Salpetriere /ID# 270220 — Paris, Île-de-France Region, France
  • University General Hospital Attikon /ID# 268555 — Chaïdári, Attica, Greece
  • General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 268762 — Nea Kifissia, Attica, Greece
  • Metropolitan Hospital /ID# 269636 — Piraeus, Attica, Greece
  • St. Luke's Hospital /ID# 269963 — Panórama, Thessaloniki, Greece
  • Theagenio Cancer Hospital /ID# 269640 — Thessaloniki, Greece
  • Rabin Medical Center. /ID# 268008 — Petah Tikva, Central District, Israel
  • 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
  • ASST Grande Ospedale Metropolitano Niguarda /ID# 269142 — Milan, Milano, Italy
  • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 269191 — Naples, Napoli, Italy
  • 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 - Rio Piedras /ID# 268809 — Rio Piedras, Puerto Rico
  • Puerto Rico Medical Research Center /ID# 268825 — San Juan, Puerto Rico
  • Hospital Universitario Marques de Valdecilla /ID# 269732 — Santander, Cantabria, Spain
  • Clinica Universidad de Navarra - Pamplona /ID# 269753 — Pamplona, Navarre, Spain
  • Hospital Universitario Vall de Hebron /ID# 270191 — Barcelona, Spain
  • Clinica Universidad de Navarra - Madrid /ID# 269754 — Madrid, Spain
  • Hospital Universitario La Paz /ID# 269730 — Madrid, Spain
  • Hospital Clinico Universitario de Valencia /ID# 269805 — Valencia, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724 — Kaohsiung City, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital /ID# 269726 — Kaohsiung City, Taiwan
  • National Cheng Kung University Hospital /ID# 270835 — Tainan, Taiwan
  • National Taiwan University Hospital /ID# 269717 — Taipei, Taiwan
  • Taipei Veterans General Hospital /ID# 269718 — Taipei, Taiwan
  • Linkou Chang Gung Memorial Hospital /ID# 269725 — Taoyuan City, Taiwan
  • Barts Health NHS Trust /ID# 271189 — London, Greater London, United Kingdom
  • Oxford University Hospitals Nhs Foundation Trust /ID# 272486 — Oxford, Oxfordshire, United Kingdom
  • The Royal Marsden - Sutton /ID# 271172 — Sutton, Surrey, United Kingdom
  • The Christie NHS Foundation Trust - Christie Hospital /ID# 271561 — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record