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Metastatic Colorectal CancerPhase 2NCT06614192

A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

A Phase 2 study testing Telisotuzumab Adizutecan in people with Metastatic Colorectal Cancer, run by AbbVie at 51 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic 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
74 participants
Where
51 sitesin 7 countries
Study dates
8 Nov 2024to Aug 2027
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

  • Life expectancy >= 12 weeks per investigator assessment.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Who cannot join

  • Prior systemic regimen containing c-MET targeting antibody/bispecific or Antibody Drug Conjugate (c-Met targeting Antibody Drug Conjugate [ADC]).
  • History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
  • Active infection as noted in the protocol.

Trial locations and contacts

51 sites in 7 countries.

51 sites in 7 countries

United States24 sites

  • Winship Cancer Institute of Emory University /ID# 266884

    Atlanta, Georgia, 30322

  • Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185

    Billings, Montana, 59102

  • St. Luke's Cancer Institute: Boise /ID# 268095

    Boise, Idaho, 83712

  • University of North Carolina Medical Center /ID# 266879

    Chapel Hill, North Carolina, 27514

  • University of Virginia /ID# 268108

    Charlottesville, Virginia, 22908

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610

    Chicago, Illinois, 60611

  • University of Texas - Southwestern Medical Center /ID# 268241

    Dallas, Texas, 75235

  • City of Hope National Medical Center /ID# 267875

    Duarte, California, 91010

  • Duke University Medical Center /ID# 267966

    Durham, North Carolina, 27710

  • West Cancer Center and Research Institute - Germantown /ID# 268619

    Germantown, Tennessee, 38138

  • Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175

    Golden, Colorado, 80401

  • Hattiesburg Clinic /ID# 267860

    Hattiesburg, Mississippi, 39401

  • Hope And Healing Cancer Services /ID# 268541

    Hinsdale, Illinois, 60521

  • The University of Texas MD Anderson Cancer Center /ID# 268098

    Houston, Texas, 77030

  • Millennium Physicians /ID# 268400

    Houston, Texas, 77090

  • Community Cancer Center North /ID# 267965

    Indianapolis, Indiana, 46250

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655

    Irvine, California, 92618

  • USC Norris Comprehensive Cancer Center /ID# 268131

    Los Angeles, California, 90033

  • Rutgers Cancer Institute of New Jersey /ID# 268056

    New Brunswick, New Jersey, 08901

  • Smilow Cancer Center At Yale-New Haven /ID# 269125

    New Haven, Connecticut, 06511

  • AdventHealth Orlando /ID# 267970

    Orlando, Florida, 32803

  • Avera Cancer Institute - Sioux Falls /ID# 268074

    Sioux Falls, South Dakota, 57105

  • Springfield Clinic - First /ID# 268666

    Springfield, Illinois, 62702

  • Washington University /ID# 267872

    St Louis, Missouri, 63110

Other trials in United States

Taiwan9 sites

  • Changhua Christian Hospital /ID# 270464

    Changhua City, Changhua County, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635

    Kaohsiung City, 807

  • Kaohsiung Chang Gung Memorial Hospital /ID# 267638

    Kaohsiung City, 833

  • China Medical University Hospital /ID# 267631

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 270467

    Taichung, 407

  • National Cheng Kung University Hospital /ID# 270468

    Tainan, 704

  • National Taiwan University Hospital /ID# 267627

    Taipei, 100

  • Taipei Veterans General Hospital /ID# 267628

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital /ID# 267637

    Taoyuan City, 333

Other trials in Taiwan

Israel6 sites

  • Rambam Health Care Campus- Haifa /ID# 267739

    Haifa, Haifa District, 3109601

  • Hadassah Medical Center-Hebrew University /ID# 267579

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center. /ID# 267740

    Petah Tikva, Central District, 4941492

  • The Chaim Sheba Medical Center /ID# 267741

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 267578

    Tel Aviv, Tel Aviv, 6423906

  • Assuta Medical Center - Tel Aviv /ID# 267745

    Tel Aviv, Tel Aviv, 6789140

Other trials in Israel

Japan5 sites

  • National Cancer Center Hospital /ID# 268713

    Chuo-Ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 268236

    Kashiwa-shi, Chiba, 277-8577

  • Saitama Prefectural Cancer Center /ID# 268706

    Kitaadachi-gun, Saitama, 362-0806

  • Aichi Cancer Center /ID# 268237

    Nagoya, Aichi-ken, 464-8681

  • The University of Osaka Hospital /ID# 268743

    Suita-shi, Osaka, 565-0871

Other trials in Japan

South Korea5 sites

  • Seoul National University Bundang Hospital /ID# 268592

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 268719

    Seoul, Seoul Teugbyeolsi, 03080

  • Yonsei University Health System Severance Hospital /ID# 268718

    Seoul, Seoul Teugbyeolsi, 03722

  • Asan Medical Center /ID# 268717

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 268720

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Australia1 site

  • Mater Misericordiae /ID# 268360

    South Brisbane, Queensland, 4101

Other trials in Australia

Puerto Rico1 site

  • Pan American Center for Oncology Trials - Rio Piedras /ID# 267888

    Rio Piedras, Puerto Rico, 00935

Other trials in Puerto Rico

About this study

Official title: AndroMETa-CRC-064: An Open-Label, Randomized Global Dose Optimization Study Comparing Two Doses of Telisotuzumab Adizutecan (ABBV-400) Monotherapy in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events and change in disease activity of intravenously (IV) infused telisotuzumab adizutecan in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC).

Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms and each treatment arm receives a different dose of telisotuzumab adizutecan. Up to approximately 60 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study at approximately 80 sites in 7 countries.

Read more

Participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. The total study duration will be approximately 4 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.

Being tested
Telisotuzumab Adizutecan
Keywords
Metastatic Colorectal Cancer, Telisotuzumab Adizutecan, ABBV-400, AndroMETa-CRC-064
Medical subject headings
Colorectal 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

Study groups in NCT06614192
Study groupRoleWhat they receive
Telisotuzumab Adizutecan Dose AExperimentalParticipants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration.
Telisotuzumab Adizutecan Dose BExperimentalParticipants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.
Receives: Drug: Telisotuzumab Adizutecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events (AE)s

    An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.

    Measured: Up to a Maximum of 4 Years

  2. Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator

    Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.

    Measured: Up to a Maximum of 4 Years

  3. Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator

    Percentage of participants with clinically significant ECGs findings as assessed by the investigator.

    Measured: Up to a Maximum of 4 Years

  4. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator

    Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.

    Measured: Up to a Maximum of 4 Years

  5. Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)

    OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

    Measured: Up to a Maximum of 4 Years

  6. Overall Survival (OS)

    OS is defined as the time from randomization to the event of death from any cause.

    Measured: Up to a Maximum of 4 Years

Secondary outcomes (15)

  1. Progression Free Survival (PFS) as Assessed by BICR

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.

    Measured: Up to a Maximum of 4 Years

  2. OS

    OS is defined as the time from randomization to the event of death from any cause

    Measured: Up to a Maximum of 4 Years

  3. Duration of Response (DOR) as Assessed by BICR

    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 BICR or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.

    Measured: Up to a Maximum of 4 Years

  4. 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, version 1.1 as determined by BICR.

    Measured: Up to a Maximum of 4 Years

  5. OR as Assessed by Investigator

    OR is defined as confirmed CR or confirmed PR as assessed by investigator per RECIST, version 1.1.

    Measured: Up to a Maximum of 4 Years

  6. PFS as Assessed by Investigator

    PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.

    Measured: Up to a Maximum of 4 Years

  7. DOR as Assessed by 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 BICR or death from any cause, whichever occurs first. DOR is defined for participants with confirmed CR/PR.

    Measured: Up to a Maximum of 4 Years

  8. Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan

    Maximum observed serum (or plasma, for payload) concentration for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  9. Time to Cmax (Tmax) for Telisotuzumab Adizutecan

    Time to Cmax for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  10. Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan

    Terminal elimination half-life for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  11. Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan

    Area under the serum (or plasma, for payload) concentration versus time curve will be determined using noncompartmental methods for total antibody for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  12. Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan

    Antibody drug conjugate for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  13. Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan

    Unconjugated Top1 inhibitor payload for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  14. Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan

    Incidence of anti-drug antibodies for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

  15. Neutralizing Anti-Drug Antibodies (nADAs) for Telisotuzumab Adizutecan

    Neutralizing anti-drug antibodies for telisotuzumab adizutecan.

    Measured: Up to a Maximum of 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start8 Nov 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06614192
Sponsor's protocol ID
M24-064
Other IDs
2024-512804-20-00
Status last verified
Sep 2026
First submitted
25 Sep 2024
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telisotuzumab Adizutecan in people with Metastatic Colorectal Cancer, run by AbbVie at 51 sites in 7 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Taiwan, Israel, Japan, South Korea and 2 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (AE)s (time frame: Up to a Maximum of 4 Years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06614192.

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 23 Sep 2026.

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