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

What this study is about

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 (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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

• 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
• 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
• 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 Medical Center /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

+ 44 more sites.

Who to contact

ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06820463.