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Clinical Trials List

Protocol NumberM24-064

NCT Number(ClinicalTrials.gov Identfier)NCT06614192

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

2026/04/22

Investigators and Locations

Principal Investigator Chang-Fang Chiu 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 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 Kun-Huei Yeh 無

National Taiwan 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 Hao-Wei Teng 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator FAN -FENG CHIANG 無

Taichung Veterans General 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 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

This trial will optimize the dose of ABBV-400 monotherapy to determine the Phase 3 recommended dose (RP3D) and evaluate the safety and efficacy of ABBV-400 monotherapy compared to LONSURF [Trifluridine and Tipiracil] plus Bevacizumab as standard of care (SOC) in patients with c-Met overexpression (OE) (defined as c-Met immunohistochemical (IHC) staining: 3+ intensity, 10% of tumor cells) refractory metastatic colorectal cancer (mCRC). Patients should have received the following treatments: fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (unless locally unapproved or unavailable), anti-EGFR monoclonal antibody (if needed), and appropriate targeted or immunotherapy (if a targetable mutation is present, such as BRAFV600E or HER2) or MSI-H/dMMR; prior treatment with Regorafenib and/or Fruquintinib is also permitted, but prior treatment with LONSURF (Trifluridine and Tipiracil) is not allowed.

Test Drug

N/A

Active Ingredient

ABBV-400

Dosage Form

N/A

Dosage

N/A

Endpoints

Phase 1:

• Optimize the dose of telisotuzumab adizutecan monotherapy to determine the recommended dose for subjects with unresectable refractory mCRC selected for a specified protein expression level.

• Evaluate the efficacy of telisotuzumab adizutecan monotherapy in subjects with unresectable refractory mCRC selected for a specified protein expression level, using objective response (OR).

• Evaluate the safety of telisotuzumab adizutecan monotherapy in subjects with unresectable refractory mCRC selected for a specified c-Met protein expression level.

Phase 2:

• Demonstrate that the objective response (OR) of telisotuzumab adizutecan is superior to that of LONSURF (trifluridine and Tipiracil) plus bevacizumab.

• Demonstrate that the overall survival (OS) of telisotuzumab adizutecan is superior to that of LONSURF plus bevacizumab.

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