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

Recruiting now · Phase 2

Conditions studied: Metastatic Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT06820463

Run by

AbbVie

People needed

390

Starts

2025-04-24

Expected to finish

2028-04-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• UCLA - Santa Monica /ID# 270621 — Santa Monica, California, United States (enrolling)
• Yale New Haven Hospital /ID# 270565 — New Haven, Connecticut, United States (enrolling)
• Northwest Georgia Oncology Centers /ID# 270245 — Marietta, Georgia, United States (enrolling)
• University of Chicago Medical Center /ID# 271688 — Chicago, Illinois, United States (enrolling)
• Hope And Healing Cancer Services /ID# 271562 — Hinsdale, Illinois, United States (enrolling)
• Dana-Farber Cancer Institute /ID# 270624 — Boston, Massachusetts, United States (enrolling)
• University Of Michigan /ID# 270790 — Ann Arbor, Michigan, United States (enrolling)
• Saint Lukes Hospital of Kansas City /ID# 270633 — Kansas City, Missouri, United States (enrolling)
• Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646 — Omaha, Nebraska, United States (enrolling)
• University of North Carolina Medical Center /ID# 267786 — Chapel Hill, North Carolina, United States (enrolling)
• Oncology Hematology Care - Eastgate /ID# 271493 — Cincinnati, Ohio, United States (enrolling)
• Texas Oncology - Austin Midtown /ID# 271354 — Austin, Texas, United States (enrolling)
• Texas Oncology - Deke Slayton Cancer Center /ID# 271355 — Webster, Texas, United States (enrolling)
• Virginia Cancer Specialists - Fairfax /ID# 271351 — Fairfax, Virginia, United States (enrolling)
• University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298 — Seattle, Washington, United States (enrolling)
• Macquarie University /ID# 271514 — Sydney, New South Wales, Australia (enrolling)
• Mater Hospital Brisbane /ID# 270694 — South Brisbane, Queensland, Australia (enrolling)
• The Queen Elizabeth Hospital /ID# 270693 — Woodville South, South Australia, Australia (enrolling)
• Austin Health /ID# 270692 — Heidelberg, Victoria, Australia (enrolling)
• One Clinical Research /ID# 270695 — Nedlands, Western Australia, Australia (enrolling)
• Medizinische Universitaet Wien /ID# 268872 — Vienna, Austria (enrolling)
• Hospital Sao Rafael /ID# 271681 — Salvador, Estado de Bahia, Brazil (enrolling)
• Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147 — Ijuí, Rio Grande do Sul, Brazil (enrolling)
• Hospital De Amor /ID# 271874 — Barretos, São Paulo, Brazil (enrolling)
• City of Hope National Medical Center /ID# 270255 — Duarte, California, United States (enrolling)

Full record on ClinicalTrials.gov

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