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NCT Number: NCT06614192

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

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.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mater Hospital Brisbane /ID# 268360, South Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Telisotuzumab Adizutecan

Drug

Intravenous (IV) Infusion

Primary outcomes

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

    Time frame: Up to a Maximum of 4 Years

    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.

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

    Time frame: Up to a Maximum of 4 Years

    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.

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

    Time frame: Up to a Maximum of 4 Years

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

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

    Time frame: Up to a Maximum of 4 Years

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

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

    Time frame: Up to a Maximum of 4 Years

    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.

  6. Overall Survival (OS)

    Time frame: Up to a Maximum of 4 Years

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

Secondary outcomes

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

    Time frame: Up to a Maximum of 4 Years

    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.

  2. OS

    Time frame: Up to a Maximum of 4 Years

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

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

    Time frame: Up to a Maximum of 4 Years

    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.

  4. Disease Control (DC) as Assessed by BICR

    Time frame: Up to a Maximum of 4 Years

    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.

  5. OR as Assessed by Investigator

    Time frame: Up to a Maximum of 4 Years

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

  6. PFS as Assessed by Investigator

    Time frame: Up to a Maximum of 4 Years

    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.

  7. DOR as Assessed by Investigator

    Time frame: Up to a Maximum of 4 Years

    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.

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

    Time frame: Up to a Maximum of 4 Years

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

  9. Time to Cmax (Tmax) for Telisotuzumab Adizutecan

    Time frame: Up to a Maximum of 4 Years

    Time to Cmax for telisotuzumab adizutecan.

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

    Time frame: Up to a Maximum of 4 Years

    Terminal elimination half-life for telisotuzumab adizutecan.

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

    Time frame: Up to a Maximum of 4 Years

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

  12. Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan

    Time frame: Up to a Maximum of 4 Years

    Antibody drug conjugate for telisotuzumab adizutecan.

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

    Time frame: Up to a Maximum of 4 Years

    Unconjugated Top1 inhibitor payload for telisotuzumab adizutecan.

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

    Time frame: Up to a Maximum of 4 Years

    Incidence of anti-drug antibodies for telisotuzumab adizutecan.

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

    Time frame: Up to a Maximum of 4 Years

    Neutralizing anti-drug antibodies for telisotuzumab adizutecan.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 26, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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