A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
Recruiting · NCT07023289 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
Standard of CareTelisotuzumab Adizutecan
What this trial is about
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Surgical tumor material should be available for Signatera ctDNA personalized panel design.
- Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.
- Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.
- Circulating tumor deoxyribonucleic acid (ctDNA) positive within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity is confirmed (reported).
- For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy.
Exclusion criteria
- No availability of surgical tissue sample.
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
Where it is running
48 locations listed across 15 US states.
- Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621 - Huntsville, Alabama, United States
- Providence Medical Foundation - Fullerton /ID# 274207 - Fullerton, California, United States
- USC Norris Comprehensive Cancer Center /ID# 274550 - Los Angeles, California, United States
- Mayo Clinic Hospital Jacksonville /ID# 274472 - Jacksonville, Florida, United States
- Moffitt Cancer Center /ID# 274372 - Tampa, Florida, United States
- University of Chicago Medical Center /ID# 274742 - Chicago, Illinois, United States
- Johns Hopkins Hospital /ID# 275645 - Baltimore, Maryland, United States
- Massachusetts General Hospital /ID# 273608 - Boston, Massachusetts, United States
- University of Michigan Health System - Ann Arbor /ID# 273511 - Ann Arbor, Michigan, United States
- Scri Minnesota Oncology Hematology, P.A. /ID# 275149 - Minneapolis, Minnesota, United States
- Mayo Clinic-Rochester /ID# 273508 - Rochester, Minnesota, United States
- Northwell Health Center for Advanced Medicine. /ID# 275331 - Lake Success, New York, United States
- Duke University Medical Center /ID# 279457 - Durham, North Carolina, United States
- Northwest Cancer Specialists /ID# 275151 - Portland, Oregon, United States
- Abramson Cancer Center at the University of Pennsylvania /ID# 275407 - Philadelphia, Pennsylvania, United States
- SCRI Oncology Partners /ID# 274522 - Nashville, Tennessee, United States
- Texas Oncology - Central/South Texas /ID# 275154 - Austin, Texas, United States
- The Center For Cancer And Blood Disorders /ID# 278512 - Fort Worth, Texas, United States
- Texas Oncology-Grapevine /ID# 275155 - Grapevine, Texas, United States
- The University of Texas MD Anderson Cancer Center /ID# 273539 - Houston, Texas, United States
- Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586 - Fairfax, Virginia, United States
- Virginia Cancer Specialists - Fairfax /ID# 274339 - Fairfax, Virginia, United States
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745 - Kaohsiung City, Taiwan
- CHU de Liege /ID# 278857 - Liège, Belgium
- Hospital Universitario La Paz /ID# 273718 - Madrid, Spain
- Hospital Universitario de Salamanca /ID# 273719 - Salamanca, Spain
- China Medical University Hospital /ID# 274644 - Taichung, Taiwan
- National Taiwan University Hospital /ID# 273580 - Taipei, Taiwan
- Aichi Cancer Center /ID# 275479 - Nagoya, Aichi-ken, Japan
- Cliniques Universitaires UCL Saint-Luc /ID# 278669 - Brussels, Brussels Capital, Belgium
- Aarhus Universitetshospital - Skejby /ID# 274498 - Aarhus, Central Jutland, Denmark
- National Cancer Center Hospital East /ID# 273614 - Kashiwa-shi, Chiba, Japan
- Azienda Ospedaliero Universitaria Careggi /ID# 273604 - Florence, Firenze, Italy
- Kyushu University Hospital /ID# 273710 - Fukuoka, Fukuoka, Japan
- Gifu University Hospital /ID# 274179 - Gifu, Gifu, Japan
- Yokohama City University Medical Center /ID# 273657 - Yokohama, Kanagawa, Japan
- IRCCS Istituto Clinico Humanitas /ID# 273566 - Rozzano, Lombardy, Italy
- Tohoku University Hospital /ID# 275481 - Sendai, Miyagi, Japan
- Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540 - Naples, Napoli, Italy
- National Hospital Organization Osaka National Hospital /ID# 274306 - Osaka, Osaka, Japan
- Odense University Hospital /ID# 274970 - Odense C, Region Syddanmark, Denmark
- Vejle Sygehus /ID# 274368 - Vejle, Region Syddanmark, Denmark
- Seoul National University Hospital /ID# 274451 - Seoul, Seoul Teugbyeolsi, South Korea
- Asan Medical Center /ID# 274454 - Seoul, Seoul Teugbyeolsi, South Korea
- Samsung Medical Center /ID# 274452 - Seoul, Seoul Teugbyeolsi, South Korea
- Hospital Universitario Virgen del Rocio /ID# 273720 - Seville, Sevilla, Spain
- Shizuoka Cancer Center /ID# 275480 - Sunto-gun, Shizuoka, Japan
- Universitair Ziekenhuis Leuven /ID# 278668 - Leuven, Vlaams-Brabant, Belgium