Solid Tumors Harboring MET Amplification
Conditions
Keywords
Solid Tumors harboring MET Amplification, Telisotuzumab Adizutecan
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 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.
Interventions
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE)s | 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. |
| Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR) | 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) criteria as appropriate to tumor type in participants with MET amplified positivity determined by FoundationOne CDx (F1CDx) testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing | Up to 36 Months | DoR is defined for confirmed responders as the time from the first documented response (initial CR or PR) until the first occurrence of radiographic progression per ICR based on RECIST v1.1 or RANO criteria as appropriate to tumor type or death from any cause, whichever occurs first. |
| Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing | Up to 36 Months | DoR is defined for confirmed responders as the time from the first documented response (initial CR or PR) until the first occurrence of radiographic progression per ICR based on RECIST v1.1 or RANO criteria as appropriate to tumor type or death from any cause, whichever occurs first. |
| 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 | DC is defined as achieving an OR or stable disease (SD) according to RECIST v1.1 by investigator at any time prior to subsequent anti-cancer therapy. |
| OS in Participants with MET Amplified Positivity Determined by F1CDx Testing | Up to 36 Months | OS is defined as the time from first dose until death from any cause. |
Countries
Israel, Japan, South Korea, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed