台灣臨床試驗主持人資料庫|TPIDB

問卷

Log In

繁中 EN

TPIDB

TPIDB Outstanding PI

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberM24-311

NCT Number(ClinicalTrials.gov Identfier)NCT06107413

2023-12-01 - 2027-03-31

Phase II

Not yet recruiting3

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 Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer

Trial Applicant

AbbVie
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Kun-Huei Yeh 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Hao-Wei Teng 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Min Yeh Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 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 Jaw-Yuan Wang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Unresectable Metastatic Colorectal Cancer

Objectives

The purpose of this trial is to confirm the optimal dose level of the investigational drug ABBV-400 in combination with 5-FU, Folinic Acid, and bevacizumab, to define a recommended Phase 3 dosing regimen for the combination therapy, and to identify patients who have previously received therapy for this colorectal cancer. To evaluate the efficacy, safety, and tolerability of the investigational drug in patients with unresectable metastatic colorectal cancer that has progressed during or after prior treatment.

Test Drug

ABBV-400

Active Ingredient

ABBV-400

Dosage Form

Powder for Concentrate for Solution for Infusion

Dosage

100 mg

Endpoints

‧Optimize the dosage of ABBV-400 combined with 5-FU, Folinic Acid and bevacizumab to determine the recommended phase 3 dose (RP3D) course of this combination therapy
‧Evaluate the efficacy based on the objective response (OR) and progression-free survival (PFS) of ABBV-400 combined with 5-FU, Folinic Acid and bevacizumab
‧Evaluate the safety and tolerability of ABBV-400 combined with 5-FU, Folinic Acid and bevacizumab

Inclution Criteria

Inclusion Criteria:

-Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
-Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

Exclusion Criteria:

-Harbor the BRAF V600E mutation.
-dMMR+/MSI-H.
-Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.
-Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.

The Estimated Number of Participants

Taiwan

20 participants
Global

206 participants