Summary
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.
Treatment Sites in Georgia
Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101