Evaluating a new treatment for 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
PHASE2 · AbbVie · NCT06820463
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie (industry) |
| Drugs / interventions | telisotuzumab, bevacizumab, panitumumab, pantitumumab |
| Locations | 44 sites (Duarte, California and 43 other locations) |
| Trial ID | NCT06820463 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with metastatic colorectal cancer who have an ECOG performance status of 0 or 1 and measurable disease.
Not a fit: Patients who have previously received systemic treatments targeting c-Met or topoisomerase inhibitors may not benefit from this study.
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 performed: Other studies have shown promise with similar combinations of chemotherapy and targeted therapies, but this specific approach with telisotuzumab adizutecan is novel.
Eligibility criteria
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 this trial is running
Duarte, California and 43 other locations
- City of Hope National Medical Center /ID# 270255 — Duarte, California, United States (RECRUITING)
- Yale New Haven Hospital /ID# 270565 — New Haven, Connecticut, 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)
- 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)
- Macquarie University /ID# 271514 — Sydney, New South Wales, Australia (RECRUITING)
- Mater Hospital Brisbane /ID# 270694 — South Brisbane, Queensland, Australia (RECRUITING)
- The Queen Elizabeth Hospital /ID# 270693 — Woodville, South Australia, Australia (RECRUITING)
- Austin Health /ID# 270692 — Heidelberg, Victoria, Australia (RECRUITING)
- One Clinical Research /ID# 270695 — Nedlands, Western Australia, Australia (RECRUITING)
- Medizinische Universitaet Wien /ID# 268872 — Vienna, Austria (RECRUITING)
- ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 270147 — Ijuí, Rio Grande do Sul, Brazil (RECRUITING)
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651 — São José do Rio Preto, São Paulo, Brazil (RECRUITING)
- Fakultní nemocnice Hradec Králové - Sokolská /ID# 268773 — Hradec Králové, Hradec Kralove, Czechia (RECRUITING)
- Fakultni Thomayerova nemocnice /ID# 269632 — Prague, Praha, Hlavni Mesto, 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)
- Hôpital Européen Georges Pompidou /ID# 270224 — Paris, France (RECRUITING)
- St. Luke's Hospital S.A. /ID# 269963 — Panórama, Thessaloniki, Greece (RECRUITING)
- Theagenio Cancer Hospital /ID# 269640 — Thessaloniki, Greece (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)
- Rabin Medical Center. /ID# 268008 — Petah Tikva, Israel (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 /ID# 268809 — Rio Piedras, Puerto Rico (RECRUITING)
- Hospital Universitario Marques de Valdecilla /ID# 269732 — Santander, Cantabria, Spain (RECRUITING)
- Hospital Universitario Vall de Hebron /ID# 270191 — Barcelona, Spain (RECRUITING)
- Kaohsiung Chang Gung Memorial Hospital /ID# 269726 — Kaohsiung City, Kaohsiung, Taiwan (RECRUITING)
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724 — Kaohsiung City, Taiwan (RECRUITING)
- National Cheng Kung University Hospital /ID# 270835 — Tainan, Taiwan (RECRUITING)
- National Taiwan University Hospital /ID# 269717 — Taipei, Taiwan (RECRUITING)
- Taipei Veterans General Hospital /ID# 269718 — Taipei, Taiwan (RECRUITING)
- Linkou Chang Gung Memorial Hospital /ID# 269725 — Taoyuan City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: ABBVIE CALL CENTER
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Colorectal Cancer, AndroMETa-CRC-533, Telisotuzumab Adizutecan