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Protocol NumberM24-534
Not yet recruiting

2025-06-25 - 2030-03-31

Phase II

Recruiting3

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, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects with Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)

  • Trial Applicant

    AbbVie

  • Sponsor

    AbbVie Pharmaceuticals GmbH Taiwan Branch

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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 Tao-Wei Ke Division of Colorectal Surgery
China Medical University Hospital

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

ctDNA-positive colorectal cancer (CRC)

Objectives

The purpose of this study is to determine whether telisotuzumab adizutecan (ABBV-400) monotherapy can delay recurrence and potentially achieve cure in patients with colorectal cancer who are ctDNA-positive following surgical resection of the tumor and adjuvant chemotherapy.

Test Drug

ABBV-400

Active Ingredient

ABBV-400

Dosage Form

N/A

Dosage

N/A

Endpoints

To evaluate the efficacy of telisotuzumab adizutecan monotherapy as measured by disease-free survival (DFS) assessed by the investigator.

To evaluate the clinical outcome of telisotuzumab adizutecan monotherapy as measured by the ctDNA clearance rate at 6 months.

To evaluate the clinical outcome of telisotuzumab adizutecan monotherapy as measured by overall survival (OS).

To evaluate the safety and tolerability of telisotuzumab adizutecan monotherapy.

To evaluate the pharmacokinetics (PK) and immunogenicity of telisotuzumab adizutecan monotherapy.

Inclution Criteria

Histologically or cytologically confirmed adenocarcinoma of the colon or rectum.

Tumor tissue obtained from surgical resection must be provided and submitted for Signatera™ personalized assay analysis and c-Met protein expression assessment.

Must have received at least 3 months of platinum-based doublet adjuvant chemotherapy; topoisomerase inhibitors must not have been part of the adjuvant regimen.

Must have no radiographic evidence of disease (NED) confirmed by CT scans of the chest, abdomen, and pelvis within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.

Must be ctDNA-positive following completion of adjuvant therapy, with study treatment initiated within 6 weeks after confirmation of ctDNA positivity.

For patients with rectal cancer, a minimum total of 3 months of perioperative and/or adjuvant platinum-based doublet therapy is required. Note: Short-course radiation or long-course chemoradiation is not counted toward the 3-month minimum perioperative/adjuvant chemotherapy requirement.

For patients with oligometastatic disease, a minimum total of 3 months of perioperative and/or adjuvant platinum-based doublet therapy is required.

Exclusion Criteria

Unable to provide surgical tumor tissue samples.

History of interstitial lung disease (ILD) or pneumonitis requiring systemic corticosteroid therapy, or evidence of active ILD or pneumonitis on screening chest CT scan.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    140 participants

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