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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center /ID# 270255 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (65 Sites)
Showing the first 25 of 65 sites.
- City of Hope National Medical Center /ID# 270255 — Duarte, California
- UCLA - Santa Monica /ID# 270621 — Santa Monica, California
- Yale New Haven Hospital /ID# 270565 — New Haven, Connecticut
- AdventHealth Orlando /ID# 270789 — Orlando, Florida
- Northwest Georgia Oncology Centers /ID# 270245 — Marietta, Georgia
- University of Chicago Medical Center /ID# 271688 — Chicago, Illinois
- Hope And Healing Cancer Services /ID# 271562 — Hinsdale, Illinois
- Dana-Farber Cancer Institute /ID# 270624 — Boston, Massachusetts
- University Of Michigan /ID# 270790 — Ann Arbor, Michigan
- Saint Lukes Hospital of Kansas City /ID# 270633 — Kansas City, Missouri
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646 — Omaha, Nebraska
- University of North Carolina Medical Center /ID# 267786 — Chapel Hill, North Carolina
- Oncology Hematology Care - Eastgate /ID# 271493 — Cincinnati, Ohio
- Texas Oncology - Austin Midtown /ID# 271354 — Austin, Texas
- Texas Oncology - Deke Slayton Cancer Center /ID# 271355 — Webster, Texas
- Virginia Cancer Specialists - Fairfax /ID# 271351 — Fairfax, Virginia
- University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298 — Seattle, Washington
- Macquarie University /ID# 271514 — Sydney, New South Wales
- Mater Misericordiae /ID# 270694 — South Brisbane, Queensland
- The Queen Elizabeth Hospital /ID# 270693 — Woodville South, South Australia
- Austin Health /ID# 270692 — Heidelberg, Victoria
- One Clinical Research /ID# 270695 — Nedlands, Western Australia
- Medizinische Universitaet Wien /ID# 268872 — Vienna,
- Hospital Sao Rafael /ID# 271681 — Salvador, Estado de Bahia
- Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147 — Ijuí, Rio Grande do Sul
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.