Actively Recruiting
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
Led by AbbVie · Updated on 2026-05-14
140
Participants Needed
44
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum
- Surgical tumor material is available for Signatera ctDNA personalized panel design
- Has received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant chemotherapy, excluding topoisomerase inhibitors in adjuvant therapy
- No radiographic evidence of disease confirmed by chest, abdominal, and pelvic CT scans within 6 weeks prior to first treatment dose
- Circulating tumor DNA (ctDNA) positive within 1 year after adjuvant therapy or tumor resection, with treatment started within 6 weeks of confirmed ctDNA positivity
- For rectal cancer, received at least 3 months of perioperative and/or adjuvant platinum-based doublet chemotherapy; short course radiation or long-course chemoradiation does not count towards this 3-month minimum
You will not qualify if you...
- No availability of surgical tissue sample
- History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids
- Any evidence of active ILD or pneumonitis on screening chest CT scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621
Huntsville, Alabama, United States, 35805
Actively Recruiting
2
Providence Medical Foundation - Fullerton /ID# 274207
Fullerton, California, United States, 92835-3826
Actively Recruiting
3
USC Norris Comprehensive Cancer Center /ID# 274550
Los Angeles, California, United States, 90033
Actively Recruiting
4
Mayo Clinic Hospital Jacksonville /ID# 274472
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Moffitt Cancer Center /ID# 274372
Tampa, Florida, United States, 33612
Actively Recruiting
6
University of Chicago Medical Center /ID# 274742
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Johns Hopkins Hospital /ID# 275645
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
University of Michigan Health System - Ann Arbor /ID# 273511
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
Scri Minnesota Oncology Hematology, P.A. /ID# 275149
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
10
Mayo Clinic-Rochester /ID# 273508
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Northwell Health Center for Advanced Medicine. /ID# 275331
Lake Success, New York, United States, 11042
Actively Recruiting
12
Duke University Medical Center /ID# 279457
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Northwest Cancer Specialists /ID# 275151
Portland, Oregon, United States, 97227-1800
Actively Recruiting
14
SCRI Oncology Partners /ID# 274522
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
Texas Oncology - Central/South Texas /ID# 275154
Austin, Texas, United States, 78705
Actively Recruiting
16
The Center For Cancer And Blood Disorders /ID# 278512
Fort Worth, Texas, United States, 76104
Actively Recruiting
17
Texas Oncology-Grapevine /ID# 275155
Grapevine, Texas, United States, 76051
Actively Recruiting
18
The University of Texas MD Anderson Cancer Center /ID# 273539
Houston, Texas, United States, 77030
Actively Recruiting
19
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586
Fairfax, Virginia, United States, 22031
Actively Recruiting
20
Virginia Cancer Specialists - Fairfax /ID# 274339
Fairfax, Virginia, United States, 22031
Actively Recruiting
21
Universitair Ziekenhuis Leuven /ID# 278668
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
22
Aarhus Universitetshospital - Skejby /ID# 274498
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
23
Odense University Hospital /ID# 274970
Odense C, Region Syddanmark, Denmark, 5000
Actively Recruiting
24
Vejle Sygehus /ID# 274368
Vejle, Region Syddanmark, Denmark, 7100
Actively Recruiting
25
Azienda Ospedaliero Universitaria Careggi /ID# 273604
Florence, Firenze, Italy, 50134
Actively Recruiting
26
IRCCS Istituto Clinico Humanitas /ID# 273566
Rozzano, Lombardy, Italy, 20089
Actively Recruiting
27
Azienda Ospedaliera Universitaria Federico II - Naples /ID# 273540
Naples, Napoli, Italy, 80131
Actively Recruiting
28
Aichi Cancer Center /ID# 275479
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
29
National Cancer Center Hospital East /ID# 273614
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
30
Kyushu University Hospital /ID# 273710
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
31
Gifu University Hospital /ID# 274179
Gifu, Gifu, Japan, 501-1194
Actively Recruiting
32
Yokohama City University Medical Center /ID# 273657
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
33
Tohoku University Hospital /ID# 275481
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
34
National Hospital Organization Osaka National Hospital /ID# 274306
Osaka, Osaka, Japan, 540-0006
Actively Recruiting
35
Shizuoka Cancer Center /ID# 275480
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
36
Seoul National University Hospital /ID# 274451
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
37
Asan Medical Center /ID# 274454
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
38
Samsung Medical Center /ID# 274452
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
39
Hospital Universitario Virgen del Rocio /ID# 273720
Seville, Sevilla, Spain, 41013
Actively Recruiting
40
Hospital Universitario La Paz /ID# 273718
Madrid, Spain, 28046
Actively Recruiting
41
Hospital Universitario de Salamanca /ID# 273719
Salamanca, Spain, 37007
Actively Recruiting
42
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745
Kaohsiung City, Taiwan, 807
Actively Recruiting
43
China Medical University Hospital /ID# 274644
Taichung, Taiwan, 40447
Actively Recruiting
44
National Taiwan University Hospital /ID# 273580
Taipei, Taiwan, 100
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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