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NCT07196644PHASE2Recruiting

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

AbbVie

Start Date

12/1/2025

Completion Date

12/1/2030

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 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.

Eligibility Criteria

Age Range: 12 years to No maximum

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.

Interventions

DRUG

Telisotuzumab Adizutecan

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Conditions

Solid Tumors Harboring MET Amplification

Locations

Beverly Hills Cancer Center /ID# 275465

Beverly Hills, California 90211

United States

City of Hope National Medical Center /ID# 275613

Duarte, California 91010

United States

Valkyrie Clinical Trials /ID# 275547

Los Angeles, California 90067

United States

Yale University School of Medicine /ID# 275978

New Haven, Connecticut 06510

United States

Florida Cancer Specialists - North /ID# 277137

St. Petersburg, Florida 33705

United States

Northwestern University Feinberg School of Medicine /ID# 276436

Chicago, Illinois 60611-2927

United States

University of Chicago Medical Center /ID# 275342

Chicago, Illinois 60637

United States

START Midwest /ID# 276603

Grand Rapids, Michigan 49546

United States

Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 275999

New York, New York 10065

United States

Duke Cancer Institute /ID# 275604

Durham, North Carolina 27710

United States

SCRI Oncology Partners /ID# 275686

Nashville, Tennessee 37203

United States

Dell Seton Medical Center /ID# 276474

Austin, Texas 78701

United States

University of Texas - Southwestern Medical Center /ID# 276053

Dallas, Texas 75235

United States

The University of Texas MD Anderson Cancer Center /ID# 275663

Houston, Texas 77030

United States

South Texas Accelerated Research Therapeutics /ID# 276608

San Antonio, Texas 78229

United States

Start Mountain Region /ID# 276607

West Valley City, Utah 84119

United States

Virginia Cancer Specialists - Fairfax /ID# 276010

Fairfax, Virginia 22031

United States

Rabin Medical Center. /ID# 274341

Petah Tikva, Central District 4941492

Israel

The Chaim Sheba Medical Center /ID# 274342

Ramat Gan, Tel Aviv 5265601

Israel

Tel Aviv Sourasky Medical Center /ID# 274344

Tel Aviv, Tel Aviv 6423906

Israel

Hadassah Medical Center-Hebrew University /ID# 274343

Jerusalem, 91120

Israel

Nagoya University Hospital /ID# 276336

Nagoya, Aichi-ken 466-8560

Japan

National Cancer Center Hospital East /ID# 276298

Kashiwa-shi, Chiba 277-8577

Japan

Kyushu University Hospital /ID# 276302

Fukuoka, Fukuoka 812-8582

Japan

Hokkaido University Hospital /ID# 276333

Sapporo, Hokkaido 060-8648

Japan

Kyoto University Hospital /ID# 276398

Kyoto, Kyoto 606-8507

Japan

Tohoku University Hospital /ID# 276344

Sendai, Miyagi 980-8574

Japan

Okayama University Hospital /ID# 276299

Okayama, Okayama-ken 700-8558

Japan

National Cancer Center Hospital /ID# 276297

Chuo-Ku, Tokyo 104-0045

Japan

Seoul National University Hospital /ID# 275703

Seoul, Seoul Teugbyeolsi 03080

South Korea

Yonsei University Health System Severance Hospital /ID# 276184

Seoul, Seoul Teugbyeolsi 03722

South Korea

Samsung Medical Center /ID# 275705

Seoul, Seoul Teugbyeolsi 06351

South Korea

Clinica Universidad de Navarra - Pamplona /ID# 275503

Pamplona, Navarre 31008

Spain

Hospital Universitario Vall de Hebron /ID# 275499

Barcelona, 08035

Spain

Hospital General Universitario Gregorio Maranon /ID# 275498

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre /ID# 275496

Madrid, 28041

Spain

Hospital Clinico Universitario de Valencia /ID# 275501

Valencia, 46010

Spain