Recruiting
Phase 2

Telisotuzumab Adizutecan

Sponsor:

AbbVie

Code:

NCT07196644

Conditions

Solid Tumors Harboring MET Amplification

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Study Details

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 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.

Conditions

Solid Tumors Harboring MET Amplification

Study ID

NCT07196644

Start date

Dec 1, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telisotuzumab Adizutecan

Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Primary outcome measure

  • Number of Participants with Adverse Events (AE)s [ Time Frame: Up to 61.5 Months ]
  • Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR) [ Time Frame: Up to 36 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Beverly Hills Cancer Center /ID# 275465

Recruiting

Beverly Hills, California, United States, 90211

City of Hope National Medical Center /ID# 275613

Recruiting

Duarte, California, United States, 91010

Valkyrie Clinical Trials /ID# 275547

Recruiting

Los Angeles, California, United States, 90067

Stanford University - Palo Alto /ID# 282083

Recruiting

Palo Alto, California, United States, 94304

Yale University School of Medicine /ID# 275978

Recruiting

New Haven, Connecticut, United States, 06510

Florida Cancer Specialists - North /ID# 277137

Recruiting

St. Petersburg, Florida, United States, 33705

Northwestern University Feinberg School of Medicine /ID# 276436

Recruiting

Chicago, Illinois, United States, 60611-2927

University of Chicago Medical Center /ID# 275342

Recruiting

Chicago, Illinois, United States, 60637

START Midwest /ID# 276603

Recruiting

Grand Rapids, Michigan, United States, 49546

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

Recruiting

New York, New York, United States, 10065

Duke Cancer Institute /ID# 275604

Recruiting

Durham, North Carolina, United States, 27710

SCRI Oncology Partners /ID# 275686

Recruiting

Nashville, Tennessee, United States, 37203

Dell Seton Medical Center /ID# 276474

Recruiting

Austin, Texas, United States, 78701

University of Texas - Southwestern Medical Center /ID# 276053

Recruiting

Dallas, Texas, United States, 75235

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

Recruiting

Houston, Texas, United States, 77030

South Texas Accelerated Research Therapeutics /ID# 276608

Recruiting

San Antonio, Texas, United States, 78229

Start Mountain Region /ID# 276607

Recruiting

West Valley City, Utah, United States, 84119

Virginia Cancer Specialists - Fairfax /ID# 276010

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AbbVie

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Solid Tumors harboring MET Amplification
  • Telisotuzumab Adizutecan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-14.