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
A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification
2 other identifiers
interventional
125
4 countries
26
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 125 participants 12 years of age or older. with solid tumors harboring MET amplification will be enrolled in the study in up to 55 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Longer than P75 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2025
CompletedFirst Posted
Study publicly available on registry
September 29, 2025
CompletedStudy Start
First participant enrolled
October 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
March 11, 2026
March 1, 2026
5.1 years
September 22, 2025
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AE)s
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 61.5 Months
Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
OR is defined as (subjects achieving complete response \[CR\] or partial response \[PR\]) as assessed by ICR based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (criteria) (RANO) criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.
Up to 36 Months
Secondary Outcomes (4)
Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
Up to 36 Months
Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
Up to 36 Months
Disease Control (DC) as Assessed by ICR based on RECIST v1.1 or RANO criteria as appropriate to tumor type in subjects with MET amplified positivity determined by F1CDx testing
Up to 36 Months
OS in Participants with MET Amplified Positivity Determined by F1CDx Testing
Up to 36 Months
Study Arms (1)
Telisotuzumab Adizutecan
EXPERIMENTALParticipants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration.
Interventions
Eligibility Criteria
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) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (26)
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
The University of Texas MD Anderson Cancer Center /ID# 275663
Houston, Texas, 77030, United States
South Texas Accelerated Research Therapeutics (START) /ID# 276608
San Antonio, Texas, 78229, United States
Start Mountain Region /ID# 276607
West Valley City, Utah, 84119, United States
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
Rabin Medical Center. /ID# 274341
Petah Tikva, 4941492, Israel
Nagoya University Hospital /ID# 276336
Nagoya, Aichi-ken, 466-8560, 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
Related Links
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2025
First Posted
September 29, 2025
Study Start
October 29, 2025
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.