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
Sponsor: AbbVie
ClinicalTrials ID:NCT07196644
This study evaluates telisotuzumab adizutecan in participants with MET-amplified solid tumors. Eligible individuals are 12+ years old, have an ECOG status of 0-1, measurable disease per RECIST 1.1 or RANO, and have exhausted other therapies. The intervention involves IV infusion of the drug. Participants will undergo regular assessments to monitor treatment effects and adverse events.
Patient Parameters
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Program Overview
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.
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center /ID# 275613 | 91010 | Duarte | California |
| Valkyrie Clinical Trials /ID# 275547 | 90067 | Los Angeles | California |
| Yale University School of Medicine /ID# 275978 | 06510 | New Haven | Connecticut |
| Florida Cancer Specialists - North /ID# 277137 | 33705 | St. Petersburg | Florida |
| Northwestern University Feinberg School of Medicine /ID# 276436 | 60611-2927 | Chicago | Illinois |
| University of Chicago Medical Center /ID# 275342 | 60637 | Chicago | Illinois |
| START Midwest /ID# 276603 | 49546 | Grand Rapids | Michigan |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 275999 | 10065 | New York | New York |
| Duke Cancer Institute /ID# 275604 | 27710 | Durham | North Carolina |
| The University of Texas MD Anderson Cancer Center /ID# 275663 | 77030 | Houston | Texas |
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