Telisotuzumab Adizutecan for Advanced Solid Tumors
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for patients aged 12 and older with specific advanced solid tumors. Participants will receive an intravenous infusion of a new drug called telisotuzumab adizutecan and will attend regular check-ups during the study.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced solid tumors that have MET amplification.
I have a performance status rating of 0 or 1.
I have measurable disease according to specific criteria.
I have received prior treatment suitable for my tumor type.
I have no good alternative treatment options that would greatly improve my survival.
If I have brain metastasis, it is stable and I have no symptoms.
You may not be able to join if
I have had or suspect I have lung disease that required steroids.
I have any life-threatening conditions and my life expectancy is less than 12 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ar…
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.
Trial Locations
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Facility
City
State
Country
Status
Eligibility Criteria
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…
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.
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