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Protocol NumberM24-533
Active

2025-05-01 - 2028-07-31

Phase II

Recruiting6

ICD-10C78.5

Secondary malignant neoplasm of large intestine and rectum

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9197.5

Secondary malignant neoplasm of large intestine and rectum

A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Telisotuzumab Adizutecan in Subjects with Metastatic Colorectal Cancer (AndroMETa-CRC-533)

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie Pharmaceuticals GmbH Taiwan Branch。

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yu-Li Su Division of Hematology & Oncology
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 Kun-Huei Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hao-Wei Teng Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Min Yeh Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-Chih Hsu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic colorectal cancer (mCRC)

Objectives

The purpose of this study is to evaluate the safety and efficacy of an investigational drug, Telisotuzumab adizutecan (ABBV-400), in combination with standard therapy in patients with metastatic colorectal cancer (mCRC).

Test Drug

ABBV-400

Active Ingredient

ABBV-400

Dosage Form

N/A

Dosage

N/A

Endpoints

• To evaluate the efficacy of telisotuzumab adizutecan in combination therapy for mCRC compared with standard-of-care treatment.
• To evaluate the safety and tolerability of telisotuzumab adizutecan in combination therapy for mCRC.
• To optimize the dosing of telisotuzumab adizutecan in combination regimens to determine the recommended Phase 3 dose (RP3D) for applicable sub-studies.
• To evaluate additional efficacy endpoints of telisotuzumab adizutecan in combination therapy for mCRC.
• To evaluate the pharmacokinetics (PK) of telisotuzumab adizutecan in combination therapy for mCRC.

Inclution Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Laboratory values meeting the protocol-defined criteria.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria

• Prior systemic therapy containing a c-MET–targeted agent (e.g., antibody, antibody–drug conjugate, or bispecific antibody) and/or any topoisomerase inhibitor (e.g., irinotecan).
• History of another malignancy within 5 years prior to screening, except for malignancies with negligible risk of metastasis or death.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    390 participants

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