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Clinical Trials List

Protocol NumberM24-533
NCT Number(ClinicalTrials.gov Identfier)NCT06820463
Active

2025-05-01 - 2028-07-31

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

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

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 Jaw-Yuan Wang Division of Colorectal Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial 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 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

The aim of this trial is to investigate the safety and efficacy of an investigational drug called Telisotuzumab adizutecan (ABBV-400) in combination with existing therapies for patients with metastatic colorectal cancer (mCRC).

Test Drug

N/A

Active Ingredient

ABBV-400

Dosage Form

N/A

Dosage

N/A

Endpoints

• Evaluate the efficacy of telisotuzumab adizutecan in combination therapy for mCRC compared to standard care.

• Evaluate the safety and tolerability of telisotuzumab adizutecan in combination therapy for mCRC.

• Optimize the dose of telisotuzumab adizutecan during the combination therapy course to determine the Phase 3 recommended dose (RP3D) in the applicable sub-trial.

• Evaluate other efficacy endpoints of telisotuzumab adizutecan in combination therapy for mCRC.

• Evaluate the pharmacokinetics (PK) of telisotuzumab adizutecan in combination therapy for mCRC.

Inclution Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Laboratory values meeting the criteria within the protocol.
Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Exclusion Criteria

Exclusion Criteria:

Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan).
History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    390 participants

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