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| ID | Type | Description | Link |
|---|---|---|---|
| EU CT | Other Identifier | 2024-512981-33-00 | |
| 2024-512981-33-00 | EU Trial (CTIS) Number |
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CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years.
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 |
|---|---|---|---|
| Substudy 1: Dose Escalation Telisotuzumab Adizutecan | Experimental | Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) and bevacizumab as part of the approximately 6 year study duration. |
|
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan High Dose | Experimental | Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
|
| Substudy 1: Dose Expansion Telisotuzumab Adizutecan Low Dose | Experimental | Participants will receive the low dose of telisotuzumab adizutecandetermined in the dose expansion arm in combination with a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
|
| Substudy 1: Dose Expansion Compatator | Experimental | Participants will receive a fixed dose of FOLFOX and bevacizumab as part of the approximately 6 year study duration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telisotuzumab Adizutecan | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1. | OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1. | Up to 24 Weeks |
| Number of Participants with Adverse Events (AE)s | An adverse event 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 Approximately 6 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by the Investigator | PFS is defined as the time from the first dose of study treatment to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier. | Up to 22 Months |
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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 |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center /ID# 270255 | Recruiting | Duarte | California | 91010 | 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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|
| Substudy 2: Dose Escalation Telisotuzumab Adizutecan | Experimental | Participants will receive various doses of telisotuzumab adizutecan in combination with a fixed dose of fluorouracil (5-FU) and leucovorin (LV) and panitumumab as part of the approximately 6 year study duration. |
|
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan High Dose | Experimental | Participants will receive the high dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration. |
|
| Substudy 2: Dose Expansion Telisotuzumab Adizutecan Low Dose | Experimental | Participants will receive the low dose of telisotuzumab adizutecan determined in the dose expansion arm in combination with a fixed dose of 5-FU/LV and panitumumab as part of the approximately 6 year study duration. |
|
| Substudy 2: Dose Expansion Compatator | Experimental | Participants will receive a fixed dose of FOLFOX and panitumumab as part of the approximately 6 year study duration. |
|
| Fluorouracil | Drug | IV Infusion; IV Injection |
|
| Oxaliplatin | Drug | IV Infusion |
|
| Leucovorin | Drug | IV Infusion; IV Injection |
|
| Bevacizumab | Drug | IV Infusion |
|
| Panitumumab | Drug | IV Infusion |
|
| Duration of Response (DOR) as Assessed by the investigator |
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first. |
| Up to 14 Months |
| Overall Survival (OS) | OS is defined as the time from first dose of study treatment to the event of death from any cause. | Up to Approximately 6 Years |
| Disease Control (DC) as Assessed by the Investigator | DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator. | Up to Approximately 6 Years |
| UCLA - Santa Monica /ID# 270621 |
| Recruiting |
| Santa Monica |
| California |
| 90404 |
| United States |
| Yale New Haven Hospital /ID# 270565 | Recruiting | New Haven | Connecticut | 06510 | United States |
| University of Chicago Medical Center /ID# 271688 | Recruiting | Chicago | Illinois | 60637 | United States |
| Hope And Healing Cancer Services /ID# 271562 | Recruiting | Hinsdale | Illinois | 60521 | United States |
| Dana-Farber Cancer Institute /ID# 270624 | Recruiting | Boston | Massachusetts | 02215 | United States |
| Saint Lukes Hospital of Kansas City /ID# 270633 | Recruiting | Kansas City | Missouri | 64111 | United States |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646 | Recruiting | Omaha | Nebraska | 68130 | United States |
| University of North Carolina Medical Center /ID# 267786 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Oncology Hematology Care - Eastgate /ID# 271493 | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Texas Oncology - Austin Midtown /ID# 271354 | Recruiting | Austin | Texas | 78705 | United States |
| Texas Oncology - Deke Slayton Cancer Center /ID# 271355 | Recruiting | Webster | Texas | 77598 | United States |
| Virginia Cancer Specialists - Fairfax /ID# 271351 | Recruiting | Fairfax | Virginia | 22031 | United States |
| University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298 | Recruiting | Seattle | Washington | 98109 | United States |
| Macquarie University /ID# 271514 | Recruiting | Sydney | New South Wales | 2109 | Australia |
| Mater Hospital Brisbane /ID# 270694 | Recruiting | South Brisbane | Queensland | 4101 | Australia |
|
| The Queen Elizabeth Hospital /ID# 270693 | Recruiting | Woodville South | South Australia | 5011 | Australia |
| Austin Health /ID# 270692 | Recruiting | Heidelberg | Victoria | 3084 | Australia |
| One Clinical Research /ID# 270695 | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| Medizinische Universitaet Wien /ID# 268872 | Recruiting | Vienna | 1090 | Austria |
| Hospital Sao Rafael /ID# 271681 | Recruiting | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147 | Recruiting | Ijuà | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital De Amor /ID# 271874 | Recruiting | Barretos | São Paulo | 14784-400 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651 | Recruiting | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 270546 | Recruiting | São Paulo | 01401-002 | Brazil |
| Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311 | Recruiting | São Paulo | 04014-002 | Brazil |
| Fakultni Thomayerova nemocnice /ID# 269632 | Recruiting | Prague | Praha, Hlavni Mesto | 140 59 | Czechia |
| Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773 | Recruiting | Hradec Králové | 500 05 | Czechia |
| Chu De Lille - Hopital Claude Huriez /ID# 270222 | Recruiting | Lille | Hauts-de-France | 59037 | France |
| Centre Hospitalier Universitaire de Poitiers /ID# 270225 | Recruiting | Poitiers | New Aquitaine | 86021 | France |
| Hôpital Européen Georges Pompidou /ID# 270224 | Recruiting | Paris | 75015 | France |
| St. Luke's Hospital /ID# 269963 | Recruiting | Panórama | Thessaloniki | 55236 | Greece |
| Theagenio Cancer Hospital /ID# 269640 | Recruiting | Thessaloniki | 54639 | Greece |
| Rabin Medical Center. /ID# 268008 | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 268010 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus- Haifa /ID# 268006 | Recruiting | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center /ID# 268009 | Recruiting | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center-Hebrew University /ID# 268007 | Recruiting | Jerusalem | 91120 | Israel |
| Aichi Cancer Center /ID# 270113 | Recruiting | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East /ID# 270114 | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| St Marianna University School Of Medicine /ID# 270111 | Recruiting | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Tohoku University Hospital /ID# 270966 | Recruiting | Sendai | Miyagi | 980-8574 | Japan |
| National Cancer Center Hospital /ID# 270112 | Recruiting | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Pan American Center for Oncology Trials - Rio Piedras /ID# 268809 | Recruiting | Rio Piedras | 00935 | Puerto Rico |
| Puerto Rico Medical Research Center /ID# 268825 | Recruiting | San Juan | 00917-5022 | Puerto Rico |
| Hospital Universitario Marques de Valdecilla /ID# 269732 | Recruiting | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario Vall de Hebron /ID# 270191 | Recruiting | Barcelona | 08035 | Spain |
| Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724 | Recruiting | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital /ID# 269726 | Recruiting | Kaohsiung City | 833 | Taiwan |
| National Cheng Kung University Hospital /ID# 270835 | Recruiting | Tainan | 704 | Taiwan |
| National Taiwan University Hospital /ID# 269717 | Recruiting | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital /ID# 269718 | Recruiting | Taipei | 112 | Taiwan |
| Linkou Chang Gung Memorial Hospital /ID# 269725 | Recruiting | Taoyuan City | 333 | Taiwan |
| The Royal Marsden - Sutton /ID# 271172 | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
| 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 |
|---|---|
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D000068258 | Bevacizumab |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| 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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