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Study of Telisotuzumab Adizutecan for Solid Tumors with MET Amplification

This study is testing an investigational drug called Telisotuzumab Adizutecan for people aged 12 and older with locally advanced or metastatic solid tumors. These tumors must have a specific genetic change called MET amplification. The main goals are to see if the drug causes any side effects (adverse events) and how it affects the disease. To join, you must have measurable disease and a good performance status. About 100 participants will receive Telisotuzumab Adizutecan through an IV infusion. The study will look at how many participants experience side effects over about 61.5 months, and how many have their tumors shrink (objective response) over about 36 months.

Study design
This study is designed with one group where all participants will receive the investigational drug, Telisotuzumab Adizutecan. Approximately 100 participants will be enrolled.
What's involved
Participants will receive Telisotuzumab Adizutecan through an intravenous (IV) infusion. The study duration for participants is up to 61.5 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events for up to 61.5 months and confirmed objective response for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07196644

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

Recruiting
PHASE2Ages 12+InterventionalTreatment
AbbVie
~100 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Telisotuzumab Adizutecan

At a glance

Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AE)s
Measured over Up to 61.5 Months
+1 more outcome measured

Conditions

Solid Tumors Harboring MET Amplification

Explore related trials

Solid NeoplasmMET Gene

Where it's being run

38 sites across 25 states
California4
Texas4
Spain4
Seoul Teugbyeolsi3
Illinois2
Tel Aviv2
Connecticut1
Florida1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Adverse Events (AE)sUp to 61.5 Months

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  • Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)Up to 36 Months

    OR is defined as (subjects achieving complete response \[CR\] or partial response \[PR\]) as assessed by ICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (criteria) (RANO) 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.