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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 51
- Primary Endpoint
- Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single group
- Primary Purpose
- Treatment
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- 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) 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.
Arms & Interventions
Telisotuzumab Adizutecan
Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration.
Intervention: Telisotuzumab Adizutecan (Drug)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing(Up to 36 Months)
- Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing(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(Up to 36 Months)
- OS in Participants with MET Amplified Positivity Determined by F1CDx Testing(Up to 36 Months)
Investigators
Study Sites (51)
Identifiers
- NCT ID
- NCT07196644
- Other Study IDs
- M25-279, 2024-518871-74-00
Dates
- First Submitted
- (last year)
- First Posted
- (last year)
- Primary Completion
- (in 4 years)
- Study Completion
- (in 4 years)
- Last Verified
- (2 months ago)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- Yes
- FDA Regulated Device
- No
- IPD Sharing Plan
- Yes
- Has Results
- No
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.