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

[M25-279]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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250443

Enrollment

Registered

2025-10-20

Start date

2025-11-28

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

Drug: telisotuzumab adizutecan iv

Eligibility

Inclusion 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

Exclusion criteria: - Current, historical, or suspected (non-infectious) interstitial lung disease (ILD)/pneumonitis. - Any major, life-threatening conditions and life expectancy should be at least 12 weeks.

Design outcomes

Primary

Measure	Time frame
- Confirmed Objective Response (OR) as Assessed by Independent Central Review(ICR) - Number of Participants with Adverse Events (AE)s	—

Secondary

Measure	Time frame
- Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing - Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing - 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 - OS in Participants with MET Amplified Positivity Determined by F1CDx Testing	—

Measure

Time frame

- Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing - Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing - 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 - OS in Participants with MET Amplified Positivity Determined by F1CDx Testing

—

Countries

Denmark, France, Israel, Japan, South Korea, Spain, Swizerland, United States

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026