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
Purpose
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.
Condition
- Solid Tumors Harboring MET Amplification
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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) 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Telisotuzumab Adizutecan |
Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration. |
|
Recruiting Locations
Los Angeles 5368361, California 5332921 90067
Chicago 4887398, Illinois 4896861 60611-2927
Chicago 4887398, Illinois 4896861 60637
Grand Rapids 4994358, Michigan 5001836 49546
New York 5128581, New York 5128638 10065
Durham 4464368, North Carolina 4482348 27710
San Antonio 4726206, Texas 4736286 78229
West Valley City 5784607, Utah 5549030 84119
More Details
- Status
- Recruiting
- Sponsor
- AbbVie