Solid Tumors Harboring MET AmplificationPhase 2NCT07196644
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 testing Telisotuzumab Adizutecan in people with Solid Tumors Harboring MET Amplification, run by AbbVie at 38 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Solid Tumors Harboring MET Amplification
- What is being tested?
- Telisotuzumab Adizutecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 1 Dec 2025to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
38 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 5 countries
United States18 sites, 18 recruiting
- Recruiting
Dell Seton Medical Center /ID# 276474
Austin, Texas, 78701
- Recruiting
Beverly Hills Cancer Center /ID# 275465
Beverly Hills, California, 90211
- Recruiting
Northwestern University Feinberg School of Medicine /ID# 276436
Chicago, Illinois, 60611-2927
- Recruiting
University of Chicago Medical Center /ID# 275342
Chicago, Illinois, 60637
- Recruiting
University of Texas - Southwestern Medical Center /ID# 276053
Dallas, Texas, 75235
- Recruiting
City of Hope National Medical Center /ID# 275613
Duarte, California, 91010
- Recruiting
Duke Cancer Institute /ID# 275604
Durham, North Carolina, 27710
- Recruiting
Virginia Cancer Specialists - Fairfax /ID# 276010
Fairfax, Virginia, 22031
- Recruiting
START Midwest /ID# 276603
Grand Rapids, Michigan, 49546
- Recruiting
The University of Texas MD Anderson Cancer Center /ID# 275663
Houston, Texas, 77030
- Recruiting
Valkyrie Clinical Trials /ID# 275547
Los Angeles, California, 90067
- Recruiting
SCRI Oncology Partners /ID# 275686
Nashville, Tennessee, 37203
- Recruiting
Yale University School of Medicine /ID# 275978
New Haven, Connecticut, 06510
- Recruiting
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 275999
New York, New York, 10065
- Recruiting
Stanford University - Palo Alto /ID# 282083
Palo Alto, California, 94304
- Recruiting
South Texas Accelerated Research Therapeutics /ID# 276608
San Antonio, Texas, 78229
- Recruiting
Florida Cancer Specialists - North /ID# 277137
St. Petersburg, Florida, 33705
- Recruiting
Start Mountain Region /ID# 276607
West Valley City, Utah, 84119
Japan8 sites, 8 recruiting
- Recruiting
National Cancer Center Hospital /ID# 276297
Chuo-Ku, Tokyo, 104-0045
- Recruiting
Kyushu University Hospital /ID# 276302
Fukuoka, Fukuoka, 812-8582
- Recruiting
National Cancer Center Hospital East /ID# 276298
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Kyoto University Hospital /ID# 276398
Kyoto, Kyoto, 606-8507
- Recruiting
Nagoya University Hospital /ID# 276336
Nagoya, Aichi-ken, 466-8560
- Recruiting
Okayama University Hospital /ID# 276299
Okayama, Okayama-ken, 700-8558
- Recruiting
Hokkaido University Hospital /ID# 276333
Sapporo, Hokkaido, 060-8648
- Recruiting
Tohoku University Hospital /ID# 276344
Sendai, Miyagi, 980-8574
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Vall de Hebron /ID# 275499
Barcelona, 08035
- Recruiting
Hospital General Universitario Gregorio Maranon /ID# 275498
Madrid, 28007
- Recruiting
Hospital Universitario 12 de Octubre /ID# 275496
Madrid, 28041
- Recruiting
Clinica Universidad de Navarra - Pamplona /ID# 275503
Pamplona, Navarre, 31008
- Recruiting
Hospital Clinico Universitario de Valencia /ID# 275501
Valencia, 46010
Israel4 sites, 4 recruiting
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 274343
Jerusalem, 91120
- Recruiting
Rabin Medical Center. /ID# 274341
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center /ID# 274342
Ramat Gan, Tel Aviv, 5265601
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 274344
Tel Aviv, Tel Aviv, 6423906
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital /ID# 275703
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Yonsei University Health System Severance Hospital /ID# 276184
Seoul, Seoul Teugbyeolsi, 03722
- Recruiting
Samsung Medical Center /ID# 275705
Seoul, Seoul Teugbyeolsi, 06351
About this study
Official title: 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
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.
Read more
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
- Being tested
- Telisotuzumab Adizutecan
- Keywords
- Solid Tumors harboring MET Amplification, Telisotuzumab Adizutecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Telisotuzumab Adizutecan | Experimental | Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration. Receives: Drug: Telisotuzumab Adizutecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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) 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.
Measured: 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
DoR is defined for confirmed responders as the time from the first documented response (initial CR or PR) until the first occurrence of radiographic progression per ICR based on RECIST v1.1 or RANO 2.0 criteria as appropriate to tumor type or death from any cause, whichever occurs first.
Measured: Up to 36 Months
Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
DoR is defined for confirmed responders as the time from the first documented response (initial CR or PR) until the first occurrence of radiographic progression per ICR based on RECIST v1.1 or RANO 2.0 criteria as appropriate to tumor type or death from any cause, whichever occurs first.
Measured: 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
DC is defined as achieving an OR or stable disease (SD) as assessed by ICR based on RECIST v1.1 or RANO 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by F1CDx testing.
Measured: Up to 36 Months
OS in Participants with MET Amplified Positivity Determined by F1CDx Testing
OS is defined as the time from first dose until death from any cause.
Measured: Up to 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors Harboring MET AmplificationStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196644
- Sponsor's protocol ID
- M25-279
- Other IDs
- 2024-518871-74-00
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07196644
- Acronym / sponsor ID
- M25-279
- Conditions
- Solid Tumors Harboring MET Amplification
- Keywords
- Solid Tumors harboring MET Amplification, Telisotuzumab Adizutecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telisotuzumab Adizutecan | Experimental | Drug: Telisotuzumab AdizutecanParticipants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telisotuzumab AdizutecanIntravenous (IV) Infusion | Drug | Telisotuzumab Adizutecan |
Primary outcome
Number of Participants with Adverse Events (AE)s
Time frame: Up to 61.5 Months
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.
Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
Time frame: Up to 36 Months
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) 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing.
4 secondary outcomes
Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
Time frame: Up to 36 Months
Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing
Time frame: 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
Time frame: Up to 36 Months
OS in Participants with MET Amplified Positivity Determined by F1CDx Testing
Time frame: Up to 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telisotuzumab Adizutecan in people with Solid Tumors Harboring MET Amplification, run by AbbVie at 38 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Japan, Spain, Israel, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AE)s (time frame: Up to 61.5 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.