Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Solid Tumors Harboring MET Amplification
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 ad...
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) 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.
Key Trial Info
Start Date :
December 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07196644
Start Date
December 4 2025
End Date
December 1 2030
Last Update
January 9 2026
Active Locations (18)
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1
Valkyrie Clinical Trials /ID# 275547
Los Angeles, California, United States, 90067
2
Northwestern University Feinberg School of Medicine /ID# 276436
Chicago, Illinois, United States, 60611-2927
3
University of Chicago Medical Center /ID# 275342
Chicago, Illinois, United States, 60637
4
START Midwest /ID# 276603
Grand Rapids, Michigan, United States, 49546