Colorectal CancerPhase 2NCT07023289
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
A Phase 2 study testing Telisotuzumab Adizutecan in people with Colorectal Cancer, run by AbbVie at 48 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Telisotuzumab Adizutecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 48 sitesin 8 countries
- Study dates
- 2 Sep 2025to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
48 sites in 8 countries
United States22 sites, 21 recruiting
- Recruiting
University of Michigan Health System - Ann Arbor /ID# 273511
Ann Arbor, Michigan, 48109
- Recruiting
Texas Oncology - Central/South Texas /ID# 275154
Austin, Texas, 78705
- Recruiting
Johns Hopkins Hospital /ID# 275645
Baltimore, Maryland, 21287
- Recruiting
Massachusetts General Hospital /ID# 273608
Boston, Massachusetts, 02114
- Recruiting
University of Chicago Medical Center /ID# 274742
Chicago, Illinois, 60637
- Recruiting
Duke University Medical Center /ID# 279457
Durham, North Carolina, 27710
- Recruiting
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586
Fairfax, Virginia, 22031
- Recruiting
Virginia Cancer Specialists - Fairfax /ID# 274339
Fairfax, Virginia, 22031
- Recruiting
The Center For Cancer And Blood Disorders /ID# 278512
Fort Worth, Texas, 76104
- Recruiting
Providence Medical Foundation - Fullerton /ID# 274207
Fullerton, California, 92835-3826
- Recruiting
Texas Oncology-Grapevine /ID# 275155
Grapevine, Texas, 76051
- Recruiting
The University of Texas MD Anderson Cancer Center /ID# 273539
Houston, Texas, 77030
- Completed
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621
Huntsville, Alabama, 35805
- Recruiting
Mayo Clinic Hospital Jacksonville /ID# 274472
Jacksonville, Florida, 32224
- Recruiting
Northwell Health Center for Advanced Medicine. /ID# 275331
Lake Success, New York, 11042
- Recruiting
USC Norris Comprehensive Cancer Center /ID# 274550
Los Angeles, California, 90033
- Recruiting
Scri Minnesota Oncology Hematology, P.A. /ID# 275149
Minneapolis, Minnesota, 55404
- Recruiting
SCRI Oncology Partners /ID# 274522
Nashville, Tennessee, 37203
- Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275407
Philadelphia, Pennsylvania, 19104
- Recruiting
Northwest Cancer Specialists /ID# 275151
Portland, Oregon, 97227-1800
- Recruiting
Mayo Clinic-Rochester /ID# 273508
Rochester, Minnesota, 55905
- Recruiting
Moffitt Cancer Center /ID# 274372
Tampa, Florida, 33612
Japan8 sites, 8 recruiting
- Recruiting
Kyushu University Hospital /ID# 273710
Fukuoka, Fukuoka, 812-8582
- Recruiting
Gifu University Hospital /ID# 274179
Gifu, Gifu, 501-1194
- Recruiting
National Cancer Center Hospital East /ID# 273614
Kashiwa-shi, Chiba, 277-8577
- Recruiting
Aichi Cancer Center /ID# 275479
Nagoya, Aichi-ken, 464-8681
- Recruiting
National Hospital Organization Osaka National Hospital /ID# 274306
Osaka, Osaka, 540-0006
- Recruiting
Tohoku University Hospital /ID# 275481
Sendai, Miyagi, 980-8574
- Recruiting
Shizuoka Cancer Center /ID# 275480
Sunto-gun, Shizuoka, 411-8777
- Recruiting
Yokohama City University Medical Center /ID# 273657
Yokohama, Kanagawa, 232-0024
Belgium3 sites, 3 recruiting
- Recruiting
Cliniques Universitaires UCL Saint-Luc /ID# 278669
Brussels, Brussels Capital, 1200
- Recruiting
Universitair Ziekenhuis Leuven /ID# 278668
Leuven, Vlaams-Brabant, 3000
- Recruiting
CHU de Liege /ID# 278857
Liège, 4000
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus Universitetshospital - Skejby /ID# 274498
Aarhus, Central Jutland, 8200
- Recruiting
Odense University Hospital /ID# 274970
Odense C, Region Syddanmark, 5000
- Recruiting
Vejle Sygehus /ID# 274368
Vejle, Region Syddanmark, 7100
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Careggi /ID# 273604
Florence, Firenze, 50134
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540
Naples, Napoli, 80138
- Recruiting
IRCCS Istituto Clinico Humanitas /ID# 273566
Rozzano, Lombardy, 20089
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital /ID# 274451
Seoul, Seoul Teugbyeolsi, 03080
- Recruiting
Asan Medical Center /ID# 274454
Seoul, Seoul Teugbyeolsi, 05505
- Recruiting
Samsung Medical Center /ID# 274452
Seoul, Seoul Teugbyeolsi, 06351
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario La Paz /ID# 273718
Madrid, 28046
- Recruiting
Hospital Universitario de Salamanca /ID# 273719
Salamanca, 37007
- Recruiting
Hospital Universitario Virgen del Rocio /ID# 273720
Seville, Sevilla, 41013
Taiwan3 sites, 3 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745
Kaohsiung City, 807
- Recruiting
China Medical University Hospital /ID# 274644
Taichung, 40447
- Recruiting
National Taiwan University Hospital /ID# 273580
Taipei, 100
About this study
Official title: A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects With Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)
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.
Read more
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
- Colorectal Cancer
- Being tested
- Telisotuzumab Adizutecan, Standard of Care
- Keywords
- Colorectal Cancer, Telisotuzumab Adizutecan, ABBV-400, Stand of Care, Cancer
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telisotuzumab AdizutecanDrug
Intravenous (IV) Infusion
Standard of CareDrug
Standard of care treatment based on investigator's judgement to the active surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Telisotuzumab Adizutecan Monotherapy | Experimental | Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration. Receives: Drug: Telisotuzumab Adizutecan |
| Standard of Care (SOC) | Active comparator | Participants will receive SOC, during the approximately 51 month study duration. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with disease free survival (DFS) Event
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
Measured: Up to Approximately 51 Months
Secondary outcomes (2)
Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
ctDNA clearance at 6 months is defined as ctDNA negative at 6 months after randomization.
Measured: 6 Months
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Measured: Up to Approximately 51 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2025
- Study start2 Sep 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023289
- Sponsor's protocol ID
- M24-534
- Other IDs
- 2024-518015-19-00
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects With Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)
- ClinicalTrials.gov ID
- NCT07023289
- Acronym / sponsor ID
- M24-534
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Telisotuzumab Adizutecan, ABBV-400, Stand of Care, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 16 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telisotuzumab Adizutecan Monotherapy | Experimental | Drug: Telisotuzumab AdizutecanParticipants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration. |
| Standard of Care (SOC) | Active comparator | Drug: Standard of CareParticipants will receive SOC, during the approximately 51 month study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telisotuzumab AdizutecanIntravenous (IV) Infusion | Drug | Telisotuzumab Adizutecan Monotherapy |
| Standard of CareStandard of care treatment based on investigator's judgement to the active surveillance. | Drug | Standard of Care (SOC) |
Primary outcome
Percentage of Participants with disease free survival (DFS) Event
Time frame: Up to Approximately 51 Months
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
2 secondary outcomes
Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
Time frame: 6 Months
Overall Survival (OS)
Time frame: Up to Approximately 51 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
48 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telisotuzumab Adizutecan in people with Colorectal Cancer, run by AbbVie at 48 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Japan, Belgium, Denmark, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with disease free survival (DFS) Event (time frame: Up to Approximately 51 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.