Recruiting

NCT Number: NCT07196644

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

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.

Recruiting

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Key information

Conditions

Solid Tumors Harboring MET Amplification

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rabin Medical Center. /ID# 274341, Petah Tikva, Central District, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telisotuzumab Adizutecan

Drug

Intravenous (IV) Infusion

Primary outcomes

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.

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

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.
Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing

Time frame: Up to 36 Months

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.
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

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.
OS in Participants with MET Amplified Positivity Determined by F1CDx Testing

Time frame: Up to 36 Months

OS is defined as the time from first dose until death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Sep 29, 2025
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.