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 now · Phase 2

Conditions studied: Solid Tumors Harboring MET Amplification

In brief

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.

Key facts

Study ID

NCT07196644

Run by

AbbVie

People needed

100

Starts

2025-12-01

Expected to finish

2030-12-01

Last updated by the study team

2026-07-27

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

• Beverly Hills Cancer Center /ID# 275465 — Beverly Hills, California, United States (enrolling)
• City of Hope National Medical Center /ID# 275613 — Duarte, California, United States (enrolling)
• Valkyrie Clinical Trials /ID# 275547 — Los Angeles, California, United States (enrolling)
• Yale University School of Medicine /ID# 275978 — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists - North /ID# 277137 — St. Petersburg, Florida, United States (enrolling)
• Northwestern University Feinberg School of Medicine /ID# 276436 — Chicago, Illinois, United States (enrolling)
• University of Chicago Medical Center /ID# 275342 — Chicago, Illinois, United States (enrolling)
• START Midwest /ID# 276603 — Grand Rapids, Michigan, United States (enrolling)
• Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 275999 — New York, New York, United States (enrolling)
• Duke Cancer Institute /ID# 275604 — Durham, North Carolina, United States (enrolling)
• SCRI Oncology Partners /ID# 275686 — Nashville, Tennessee, United States (enrolling)
• Dell Seton Medical Center /ID# 276474 — Austin, Texas, United States (enrolling)
• University of Texas - Southwestern Medical Center /ID# 276053 — Dallas, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center /ID# 275663 — Houston, Texas, United States (enrolling)
• South Texas Accelerated Research Therapeutics /ID# 276608 — San Antonio, Texas, United States (enrolling)
• Start Mountain Region /ID# 276607 — West Valley City, Utah, United States (enrolling)
• Virginia Cancer Specialists - Fairfax /ID# 276010 — Fairfax, Virginia, United States (enrolling)
• Rabin Medical Center. /ID# 274341 — Petah Tikva, Central District, Israel (enrolling)
• The Chaim Sheba Medical Center /ID# 274342 — Ramat Gan, Tel Aviv, Israel (enrolling)
• Tel Aviv Sourasky Medical Center /ID# 274344 — Tel Aviv, Tel Aviv, Israel (enrolling)
• Hadassah Medical Center-Hebrew University /ID# 274343 — Jerusalem, Israel (enrolling)
• Nagoya University Hospital /ID# 276336 — Nagoya, Aichi-ken, Japan (enrolling)
• National Cancer Center Hospital East /ID# 276298 — Kashiwa-shi, Chiba, Japan (enrolling)
• Kyushu University Hospital /ID# 276302 — Fukuoka, Fukuoka, Japan (enrolling)
• Hokkaido University Hospital /ID# 276333 — Sapporo, Hokkaido, Japan (enrolling)

Full record on ClinicalTrials.gov

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