A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizute… (NCT06820463) | Clinical Trial Compass
RecruitingPhase 2
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
United States, Australia, Austria390 participantsStarted 2025-04-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines telisotuzumab adizutecan with several existing chemotherapy and targeted drugs like oxaliplatin, fluorouracil, bevacizumab, and panitumumab — given that this is a Phase 2 study, how much is currently known about whether this specific combination is safe, and are there any side effects from combining these drugs that I should be especially aware of?
2The trial is measuring how many people have a complete or partial tumor response using RECIST criteria — based on my tumor type, location, and any biomarkers I have, does my doctor think I'd be a realistic candidate to see that kind of response, and how does that compare to what standard first-line treatment might offer me?
3Since this is still a Phase 2 trial, meaning it hasn't yet moved into the larger confirmatory phase, what would my doctor say about weighing the potential benefits of this experimental combination against just starting with an established standard-of-care regimen for metastatic colorectal cancer right now?
4The regimen in this trial involves multiple IV medications given together, which likely means frequent clinic visits and infusions — how time-intensive would my treatment schedule realistically be, and is that something worth discussing given my current health, work situation, and support at home?
5Telisotuzumab adizutecan is a newer drug being studied here — has my doctor seen data from earlier studies of this drug, and are there specific toxicities associated with it that I should understand before considering this combination trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1.