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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521712-19-00 | Other Identifier | EU CT |
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Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.
In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ph 3: Telisotuzumab Adizutecan + Bevacizumab | Experimental | Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration. |
|
| Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab | Experimental | Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telisotuzumab adizutecan | Drug | Intravenous (IV) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) | Confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to Approximately 15 Months |
| Phase 3: Overall Survival (OS) | OS is defined as the time from randomization to the event of death from any cause. | Up to Approximately 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) | PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier. | Up to Approximately 24 Months |
| Phase 3: Duration Of Response (DoR) as assessed by BICR |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Astera Cancer Care /ID# 279532 | Recruiting | East Brunswick | New Jersey | 08816-4096 | 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/
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| Bevacizumab |
| Drug |
Intravenous (IV) |
|
| Trifluridine/Tipiracil | Drug | Oral |
|
DoR defined as time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR. |
| Up to Approximately 24 Months |
| Phase 3: Disease Control (DC) as assessed by BICR: | DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1 | Up to Approximately 24 Months |
| Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13 | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). | Up to Approximately 13 Weeks |
| Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). | Up to Approximately 13 Weeks |
| University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 |
| Recruiting |
| Seattle |
| Washington |
| 98109 |
| United States |
| Algemeen Ziekenhuis klina /ID# 279331 | Not yet recruiting | Brasschaat | Antwerpen | 2930 | Belgium |
| National Cancer Center Hospital East /ID# 279917 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| Unidade Local de Saude de Loures-Odivelas /ID# 279636 | Recruiting | Loures | Lisbon District | 2674-514 | Portugal |
| Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 | Recruiting | Almada | Setúbal District | 2805-267 | Portugal |
| Dong-A University Medical Center /ID# 279610 | Recruiting | Busan | Busan Gwang Yeogsi | 49201 | South Korea |
| Gachon University Gil Medical Center /ID# 279592 | Recruiting | Incheon | Gyeonggido | 21565 | South Korea |
| Taipei Medical University Hospital /ID# 280607 | Recruiting | Taipei | Tainan | 110 | Taiwan |
| E-Da Cancer Hospital /ID# 279745 | Recruiting | Kaohsiung City | 824 | Taiwan |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708 | Recruiting | New Taipei City | 235 | Taiwan |
| Chi Mei Medical Center /ID# 279710 | Recruiting | Tainan | 71004 | Taiwan |
| Tri-Service General Hospital - Neihu Branch /ID# 279768 | Recruiting | Taipei | 114 | Taiwan |
| Taipei Municipal Wan Fang Hospital /ID# 280285 | Recruiting | Taipei | 116 | Taiwan |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000613803 | trifluridine tipiracil drug combination |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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