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Clinical Trials List

Protocol NumberM24-064
NCT Number(ClinicalTrials.gov Identfier)NCT06614192
Active

2024-11-01 - 2029-08-31

Phase III

Recruiting10

ICD-10C18.3

Malignant neoplasm of hepatic flexure

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9153.0

Malignant neoplasm of hepatic flexure colon

AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 陳彥勳 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Chih Hsu 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Kun-Huei Yeh 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Li Su 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hao-Wei Teng 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chang-Fang Chiu 無
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴冠銘 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jaw-Yuan Wang 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator FAN -FENG CHIANG Division of Colorectal Surgery
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Colorectal Cancer

Objectives

Colorectal cancer (CRC) is the third most common type of cancer diagnosed globally and in China. The aim of this trial was to compare intravenous (IV) infusion of ABBV-400 with oral trifluridine and tipiracil (LONSURF) tablets plus IV infusion of bevacizumab in adult subjects with refractory metastatic colorectal cancer whose c-Met protein expression exceeds a specified threshold, and to assess adverse event disease activity.

Test Drug

N/A

Active Ingredient

ABBV-400

Dosage Form

N/A

Dosage

NA

Endpoints

Phase 1:

• Percentage of participants experiencing adverse events.

• Percentage of participants whose researchers assessed clinically significant vital sign measurements.

• Percentage of participants whose researchers assessed clinically significant electrocardiogram (ECG) results.

• Percentage of participants whose researchers assessed clinically significant laboratory values ​​(chemistry, hematology, coagulation, and urinalysis).

Phase 2:

• Overall survival (OS).

Phase 1 and 2:

• Objective response (OR) assessed by blinded independent central review (BICR).

Inclution Criteria

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

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.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    460 participants

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