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Telisotuzumab adizutecan for advanced solid tumors with MET amplification (ages 12+)

A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification

Phase 2 Interventional AbbVie · NCT07196644

This trial will try an IV drug called telisotuzumab adizutecan in people 12 years and older whose advanced solid tumors have MET amplification to see if it can control tumor activity and what side effects occur.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment125 (estimated)
Ages12 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionstelisotuzumab
Locations26 sites (Duarte, California and 25 other locations)
Trial IDNCT07196644 on ClinicalTrials.gov

What this trial studies

This is a single-arm Phase 2 trial enrolling about 125 participants with locally advanced or metastatic solid tumors that harbor MET amplification, treated at up to 55 sites worldwide. Participants receive intravenous telisotuzumab adizutecan and are followed for safety and change in disease activity over a planned study period of about 61.5 months. Key eligibility includes documented MET amplification by NGS, ECOG performance status 0–1, measurable disease per RECIST or RANO as appropriate, and prior systemic therapy with no satisfactory alternative. The study will collect adverse event data and tumor response measurements to characterize safety and clinical activity of the agent in this molecularly defined population.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 or older with locally advanced or metastatic solid tumors that have documented MET amplification, good performance status (ECOG 0–1), measurable disease, and prior appropriate systemic therapy without satisfactory alternatives.

Not a fit: Patients whose tumors do not have MET amplification, who have poor performance status, or who have significant active lung disease or other exclusionary comorbidities are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, the drug could offer a new targeted treatment option that controls disease in patients whose tumors have MET amplification and who lack satisfactory standard therapies.

How similar studies have performed: Early-phase studies of telisotuzumab adizutecan and other MET-targeting agents have shown preliminary signs of activity in MET-amplified tumors, but results remain preliminary and are not yet definitive.

Eligibility criteria

Show full inclusion / exclusion 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 baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Response Assessment in Neuro-Oncology (RANO) 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.

Where this trial is running

Duarte, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumors Harboring MET AmplificationSolid Tumors harboring MET AmplificationTelisotuzumab Adizutecan
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.