Evaluating a new treatment for metastatic colorectal cancer
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
Run by AbbVie · NCT06820463 · Data updated 2026-11-12
This study is testing a new drug combined with standard chemotherapy to see if it helps adults with metastatic colorectal cancer feel better and improve their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 390 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | telisotuzumab, bevacizumab, panitumumab, pantitumumab |
| Locations | 82 sites (Duarte, California and 81 other locations) |
| Status | Recruiting |
| Started | April 24, 2025 |
| Main results expected | March 2028 |
| Study ends | April 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06820463 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with metastatic colorectal cancer who have an ECOG performance status of 0 or 1 and measurable disease.
✕Probably not a fit
Patients who have previously received systemic treatments targeting c-Met or topoisomerase inhibitors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the safety and efficacy of telisotuzumab adizutecan when combined with standard chemotherapy agents like oxaliplatin, fluorouracil, leucovorin, and targeted therapies such as bevacizumab or panitumumab in adults with metastatic colorectal cancer. The trial is structured in two stages, starting with dose escalation to determine the maximum tolerable dose before randomizing participants into treatment arms. The goal is to evaluate adverse events and changes in disease activity associated with this investigational drug.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic colorectal cancer.
How similar studies have gone: Other studies have shown promise with similar combinations of chemotherapy and targeted therapies, but this specific approach with telisotuzumab adizutecan is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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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
Show 44 more locations
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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 at Chapel Hill /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 /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 -
Medizinische Universitaet Graz /ID# 268876
Graz, Styria, Austria 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 -
Centre Hospitalier Regional Universitaire 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 -
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 270221
Nantes, Pays de la Loire Region, France Recruiting -
Hopital Europeen Georges Pompidou /ID# 270224
Paris, France Recruiting -
Hopital Pitie Salpetriere /ID# 270220
Paris, Île-de-France Region, France Recruiting -
University General Hospital Attikon /ID# 268555
Chaïdári, Attica, Greece Recruiting -
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 268762
Nea Kifissia, Attica, Greece Recruiting -
Metropolitan Hospital /ID# 269636
Piraeus, Attica, Greece Recruiting -
St. Luke's Hospital /ID# 269963
Panórama, Thessaloniki, Greece Recruiting
+32 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing new treatments for metastatic colorectal cancer with a specific mutation
This study is testing if a new combination of treatments can help people with a specific type of metastatic colorectal cancer feel better compared to standard treatments.
-
Comparing two treatments for metastatic colorectal cancer
This study is testing which combination of treatments works better for people with metastatic colorectal cancer: one with panitumumab or the other with bevacizumab.
-
Second-line combination treatment for MSS metastatic colorectal cancer
This trial will try folinic acid plus continuous 5-FU with liposomal irinotecan, sometimes combined with cetuximab or bevacizumab, as a second-line option for adults with MSS metastatic colorectal cancer who progressed on or cannot tolerate oxaliplatin-based therapy.
-
Comparing Precem-TcT (with or without bevacizumab) versus trifluridine/tipiracil plus bevacizumab for people with previously treated metastatic colorectal cancer
This trial will see if Precem-TcT, alone or with bevacizumab, helps people with metastatic colorectal cancer who have already received standard chemotherapy, compared with trifluridine/tipiracil plus bevacizumab.
-
Telisotuzumab Adizutecan with Bevacizumab vs LONSURF with Bevacizumab in refractory metastatic colorectal cancer
This study tests whether adding telisotuzumab adizutecan to bevacizumab helps adults with refractory metastatic colorectal cancer more than the standard care of LONSURF plus bevacizumab.
-
Elovie (bevacizumab biosimilar) for metastatic colorectal cancer in Brazil
This project will see if the biosimilar bevacizumab Elovie works well and is safe for adults in Brazil with unresectable stage IV metastatic colorectal cancer receiving first-line therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.