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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beverly Hills Cancer Center /ID# 275465
  Beverly Hills, California, United States Recruiting
• City of Hope National Medical Center /ID# 275613
  Duarte, California, United States Recruiting
• Valkyrie Clinical Trials /ID# 275547
  Los Angeles, California, United States Recruiting
• Stanford University - Palo Alto /ID# 282083
  Palo Alto, California, United States Recruiting
• Yale University School of Medicine /ID# 275978
  New Haven, Connecticut, United States Recruiting
• Florida Cancer Specialists - North /ID# 277137
  St. Petersburg, Florida, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Telisotuzumab Adizutecan with Bevacizumab vs LONSURF with Bevacizumab in refractory metastatic colorectal cancer

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• IV telisotuzumab adizutecan versus standard treatment for adults with advanced EGFR‑mutated non‑squamous NSCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.