臨床研究等提出・公開システム

[M24-064] AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study
Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects
with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused
ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants
with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

Yamagishi Chika

AbbVie GK

3-1-21, Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie GK

3-1-21, Shibaura, Minato-ku Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Recruiting

Feb. 17, 2025

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

- Life expectancy >= 12 weeks per investigator assessment.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period prior to the first dose of the study drug.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
- Subject has received the following regimens for the treatment of advanced colorectal cancer and has demonstrated progressive disease or intolerance to their last regimen.
- Prior treatment regimens must have included a fluoropyrimidine (e.g., 5-fluorouracil or capecitabine), irinotecan, oxaliplatin, and an anti-VEGF monoclonal antibody (unless locally not approved) and an anti-EGFR antibody if indicated.
- Patients who have received adjuvant/neoadjuvant chemotherapy and had recurrence during or within 12 months of completion of the adjuvant/neoadjuvant chemotherapy can count the adjuvant/neoadjuvant therapy as one regimen of therapy for advanced disease.
- Prior treatment of Regorafenib and/or Fruquintinib is also allowed.
- Must not have received prior LONSURF (Trifluridine/Tipiracil) treatment.
- Patients who are BRAFV600E or HER2 amplified should have received approved target therapy (unless locally not approved or clinically contraindicated).
- Patients who are MSI-high/dMMR should have received approved immunotherapy (unless locally not approved or clinically contraindicated).
- Patients who have other targetable mutations should have been treated with the appropriate drug as it becomes approved, unless clinically contraindicated.
- Must not have received anticancer therapy used with an antineoplastic intent, 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 study drug.
Note:Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period.

- Prior systemic regimen containing c-MET targeting antibody or Antibody Drug Conjugate (ADC).
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
- Active infection as noted in the protocol.

Metastatic Colorectal Cancer

- Drug: ABBV-400
Intravenous (IV) Infusion
- Drug: Trifluridine/Tipiracil
Oral Tablet
- Drug: Bevacizumab
Intravenous (IV) Infusion

Stage 1 and Stage 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Stage 1: Percentage of Participants with Adverse Events (AE)s
Stage 1: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Stage 1: Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Stage 1: Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
Stage 2: Overall Survival (OS)

Stage 1 and Stage 2: DOR as Assessed by Investigator
Stage 1: Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for ABBV-400
Stage 1 and Stage 2: Progression Free Survival (PFS) as Assessed by BICR
Stage 1 and Stage 2: Duration of Response (DOR) as Assessed by BICR
Stage 1 and Stage 2: OR as Assessed by Investigator
Stage 1 and Stage 2: Disease Control (DC) as Assessed by BICR
Stage 1 and Stage 2: PFS as Assessed by Investigator
Stage 1: OS
Stage 1: Incidence of Anti-Drug Antibodies (ADAs) for ABBV-400
Stage 1: Neutralizing Anti-Drug Antibodies (nADAs) for ABBV-400
Stage 1: Time to Cmax (Tmax) for ABBV-400
Stage 1: Terminal Elimination Half-Life (t1/2) for ABBV-400
Stage 1: Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for ABBV-400
Stage 1: Antibody Drug Conjugate (ADC) for ABBV-400
Stage 1: Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for ABBV-400
Stage 2: Change from Baseline at C5D1 (ABBV-400 Arm) in Physical Functioning as Measured by the Physical Functioning Domain of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Stage 2: Change from Baseline at C7D1 (Standard of Care [SOC] Arm) in Physical Functioning as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Stage 2: Change from Baseline at C7D1 (SOC Arm) in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Stage 2: Change from Baseline at C5D1 (ABBV-400 Arm) in in Diarrhea as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Stage 2: Change from Baseline at C5D1 (ABBV-400 Arm) in in Global Health Status (GHS)/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30
Stage 2: Change from Baseline at C7D1 (SOC Arm) in GHS/QoL as Measured by the Physical Functioning Domain of the EORTC QLQ-C30

+81-3-3542-2511

Jan. 20, 2025

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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