Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518871-74-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telisotuzumab Adizutecan | Experimental | Participants will receive telisotuzumab adizutecan, as part of the 61.5 month study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telisotuzumab Adizutecan | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE)s | 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. | Up to 61.5 Months |
| Confirmed Objective Response (OR) as Assessed by Independent Central Review (ICR) | 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. | Up to 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing | 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 2.0 criteria as appropriate to tumor type or death from any cause, whichever occurs first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center /ID# 275465 | Recruiting | Beverly Hills | California | 90211 | United States | |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 36 Months |
| Progression-Free Survival (PFS) as Assessed by ICR in participants with MET amplified positivity determined by F1CDx testing | 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 2.0 criteria as appropriate to tumor type or death from any cause, whichever occurs first. | 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 | DC is defined as achieving an OR or stable disease (SD) as assessed by ICR based on RECIST v1.1 or RANO 2.0 criteria as appropriate to tumor type in participants with MET amplified positivity determined by F1CDx testing. | Up to 36 Months |
| OS in Participants with MET Amplified Positivity Determined by F1CDx Testing | OS is defined as the time from first dose until death from any cause. | Up to 36 Months |
| City of Hope National Medical Center /ID# 275613 |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| Valkyrie Clinical Trials /ID# 275547 | Recruiting | Los Angeles | California | 90067 | United States |
| Yale University School of Medicine /ID# 275978 | Recruiting | New Haven | Connecticut | 06510 | United States |
| Florida Cancer Specialists - North /ID# 277137 | Recruiting | St. Petersburg | Florida | 33705 | United States |
| Northwestern University Feinberg School of Medicine /ID# 276436 | Recruiting | Chicago | Illinois | 60611-2927 | United States |
| University of Chicago Medical Center /ID# 275342 | Recruiting | Chicago | Illinois | 60637 | United States |
| START Midwest /ID# 276603 | Recruiting | Grand Rapids | Michigan | 49546 | United States |
| Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 275999 | Recruiting | New York | New York | 10065 | United States |
| Duke Cancer Institute /ID# 275604 | Recruiting | Durham | North Carolina | 27710 | United States |
| SCRI Oncology Partners /ID# 275686 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Dell Seton Medical Center /ID# 276474 | Recruiting | Austin | Texas | 78701 | United States |
| UT Southwestern Medical Center /ID# 276053 | Recruiting | Dallas | Texas | 75390 | United States |
| The University of Texas MD Anderson Cancer Center /ID# 275663 | Recruiting | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics (START) /ID# 276608 | Recruiting | San Antonio | Texas | 78229 | United States |
| Start Mountain Region /ID# 276607 | Recruiting | West Valley City | Utah | 84119 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 276010 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Rabin Medical Center. /ID# 274341 | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| The Chaim Sheba Medical Center /ID# 274342 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 274344 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 274343 | Recruiting | Jerusalem | 91120 | Israel |
| Nagoya University Hospital /ID# 276336 | Recruiting | Nagoya | Aichi-ken | 466-8560 | Japan |
| National Cancer Center Hospital East /ID# 276298 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Kyushu University Hospital /ID# 276302 | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
| Hokkaido University Hospital /ID# 276333 | Recruiting | Sapporo | Hokkaido | 060-8648 | Japan |
| Kyoto University Hospital /ID# 276398 | Recruiting | Kyoto | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital /ID# 276344 | Recruiting | Sendai | Miyagi | 980-8574 | Japan |
| Okayama University Hospital /ID# 276299 | Recruiting | Okayama | Okayama-ken | 700-8558 | Japan |
| National Cancer Center Hospital /ID# 276297 | Recruiting | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Seoul National University Hospital /ID# 275703 | Recruiting | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 276184 | Recruiting | Seoul | Seoul Teugbyeolsi | 03722 | South Korea |
| Samsung Medical Center /ID# 275705 | Recruiting | Seoul | Seoul Teugbyeolsi | 06351 | South Korea |
| Clinica Universidad de Navarra - Pamplona /ID# 275503 | Recruiting | Pamplona | Navarre | 31008 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 275498 | Recruiting | Madrid | 28007 | Spain |