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Clinical Trials List

Protocol NumberM24-311
NCT Number(ClinicalTrials.gov Identfier)NCT06107413
Active

2023-12-01 - 2027-03-31

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

  • Trial Applicant

    AbbVie

  • Sponsor

  • 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 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-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 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 Hematology & Oncology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

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

Unresectable Metastatic Colorectal Cancer

Objectives

The purpose of this trial is to determine the optimal dose order of the investigational drug ABBV-400 in combination with 5-FU, Folinic Acid, and bevacizumab to define the recommended dose course for phase 3 of the combination therapy, and to evaluate the efficacy, safety, and tolerability of the investigational drug in patients with unresectable metastatic colorectal cancer who have previously received therapy for this colorectal cancer and whose cancer has progressed during or after previous treatment.

Test Drug

N/A
N/A
N/A
N/A
N/A

Active Ingredient

ABBV-400
Bevacizumab
Folinic Acid
Fluorouracil
Irinotecan

Dosage Form

N/A
N/A
N/A
N/A
N/A

Dosage

NA

Endpoints

• Optimize the dosage of ABBV-400 combined with 5-FU, Folinic Acid, and bevacizumab to determine the Phase 3 Recommended Dosage-Per-Day (RP3D) course of this combination therapy.

• Efficacy is assessed based on objective response (OR) and progression-free survival (PFS) of ABBV-400 combined with 5-FU, Folinic Acid, and bevacizumab.

• Assess 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.
Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.

Exclusion Criteria

Exclusion Criteria:

Harbor the BRAF V600E mutation.
dMMR+/MSI-H.
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

    280 participants

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