A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age o… (NCT07196644) | Clinical Trial Compass
RecruitingPhase 2
A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan
United States, Israel, Japan100 participantsStarted 2025-12-01
Plain-language summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of locally advanced or metastatic solid tumors that harbor MET amplification. This study will have 1 arm where participants will receive telisotuzumab adizutecan. Approximately 100 participants 12 years of age or older. with solid tumors harboring MET amplification will be enrolled in the study in up to 50 sites around the world.
Participants will receive intravenous (IV) telisotuzumab adizutecan, as part of the 61.5 month study duration.
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
12 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:
* Locally advanced/metastatic solid tumors with documented MET amplification via Local next generation sequencing (NGS) or Central NGS via FoundationOne Companion Diagnostic (F1CDx).
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
* Measurable disease at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) 2.0 criteria as appropriate to tumor type.
* Received prior systemic therapy appropriate for their tumor type and stage of disease and who have no satisfactory alternative therapy for advanced solid tumors that would be expected to provide a substantial survival benefit for their tumor type.
* If participant has central nervous system (CNS) metastasis, these should be clinically asymptomatic or radiologically stable (i.e., without evidence of progression after definitive treatment).
Exclusion Criteria:
* Current, historical, or suspected (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids.
* Any major, life-threatening conditions and life expectancy should be at least 12 weeks.
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 is a Phase 2 trial, which means researchers are still gathering early data on safety and effectiveness — does what's known so far about telisotuzumab adizutecan suggest it could be a reasonable option for my specific tumor type and MET amplification status, compared to standard treatments available to me?
2The trial is specifically enrolling people whose tumors have MET amplification — how would my tumor be tested to confirm I have that, and do I already have that result from my current workup?
3One of the main things this trial is measuring is the number of participants who experience adverse events — based on what's known about this drug class so far, what kinds of side effects should I be prepared for, and how are they typically managed?
4Since this drug is given intravenously, how often would I need to come in for infusions, and how might that schedule realistically fit with my work, caregiving responsibilities, or travel situation?
5Given that this trial is still in Phase 2 and actively recruiting, would it make more sense for me to try an established standard-of-care option first, or is there a reason you'd recommend considering this trial at this stage of my diagnosis?
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
Number of Participants with Adverse Events (AE)s
Timeframe: Up to 61.5 Months
2
Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)