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

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

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 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.

Interventions

• Drug Telisotuzumab Adizutecan
  Intravenous (IV) Infusion

Primary outcome measures

• Number of Participants with Adverse Events (AE)s [Time frame: Up to 61.5 Months]
• Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR) [Time frame: Up to 36 Months]

Secondary outcome measures (4)

• 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]

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) 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 17 centers

• Beverly Hills Cancer Center /ID# 275465 — Beverly Hills
• City of Hope National Medical Center /ID# 275613 — Duarte
• Valkyrie Clinical Trials /ID# 275547 — Los Angeles
• Yale University School of Medicine /ID# 275978 — New Haven
• Florida Cancer Specialists - North /ID# 277137 — St. Petersburg
• Northwestern University Feinberg School of Medicine /ID# 276436 — Chicago
• University of Chicago Medical Center /ID# 275342 — Chicago
• START Midwest /ID# 276603 — Grand Rapids
• … and 9 more centers

Japan · 8 centers

• Nagoya University Hospital /ID# 276336 — Nagoya
• National Cancer Center Hospital East /ID# 276298 — Kashiwa-shi
• Kyushu University Hospital /ID# 276302 — Fukuoka
• Hokkaido University Hospital /ID# 276333 — Sapporo
• Kyoto University Hospital /ID# 276398 — Kyoto
• Tohoku University Hospital /ID# 276344 — Sendai
• Okayama University Hospital /ID# 276299 — Okayama
• National Cancer Center Hospital /ID# 276297 — Chuo-Ku

Spain · 5 centers

• Clinica Universidad de Navarra - Pamplona /ID# 275503 — Pamplona
• Hospital Universitario Vall de Hebron /ID# 275499 — Barcelona
• Hospital General Universitario Gregorio Maranon /ID# 275498 — Madrid
• Hospital Universitario 12 de Octubre /ID# 275496 — Madrid
• Hospital Clinico Universitario de Valencia /ID# 275501 — Valencia

Israel · 4 centers

• Rabin Medical Center. /ID# 274341 — Petah Tikva
• The Chaim Sheba Medical Center /ID# 274342 — Ramat Gan
• Tel Aviv Sourasky Medical Center /ID# 274344 — Tel Aviv
• Hadassah Medical Center-Hebrew University /ID# 274343 — Jerusalem

South Korea · 3 centers

• Seoul National University Hospital /ID# 275703 — Seoul
• Yonsei University Health System Severance Hospital /ID# 276184 — Seoul
• Samsung Medical Center /ID# 275705 — Seoul

Identifiers

NCT: NCT07196644 · M25-279 · 2024-518871-74-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗