NCT07525206 · AbbVie
A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer
(AndroMETa-CRC)
What this study is about
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the side effects and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to the usual treatment (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an experimental drug being developed for the treatment of CRC. Participants will then be randomly assigned into 2 groups called treatment treatment group$1. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive the usual treatment (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of given through a vein (IV) (IV) telisotuzumab adizutecan + bevacizumab and other group will receive taken by mouth SOC of trifluridine/tipiracil (LONSURF)+ given through a vein (IV) (IV) bevacizumab. The study will run for a duration of approximately of 36 months. There may be higher treatment burden for participants in this trial compared to their the usual treatment. 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.
View original scientific description
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months. 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.
Interventions
DRUG
Telisotuzumab adizutecan
Intravenous (IV)
DRUG
Bevacizumab
Intravenous (IV)
DRUG
Trifluridine/Tipiracil
Oral
Primary outcome measures
Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
Time frame: Up to Approximately 15 Months
Confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Phase 3: Overall Survival (OS)
Time frame: Up to Approximately 36 Months
OS is defined as the time from randomization to the event of death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.
- Life expectancy \>= 12 weeks per investigator assessment
Exclusion criteria
- Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
- History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
Where
- East Brunswick, New Jersey
- Lake Success, New York
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations