Colorectal Cancer
Conditions
Interventions
Drug: Telisotuzumab Adizutecan Intravenous (IV)
Drug: Bevacizumab Intravenous (IV)
Drug: Trifluridine/Tipiracil Oral
Sponsors
Yamagishi Chika
Eligibility
Inclusion criteria
Inclusion criteria: - Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator - Individuals at least 18 years old - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Participant has histologically or cytologically confirmed unresectable, metastatic adenocarcinoma of the colon or rectum - Participant has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Participant has received treatment with the following regimens for the treatment of advanced colorectal cancer (CRC) and has demonstrated progressive disease (PD) 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 mAb and an anti-EGFR antibody - Must not have received prior regorafenib, fruquintinib, or trifluridine and tipiracil treatment
Exclusion criteria
Exclusion criteria: - Prior systemic regimen containing c-Met targeting agent(e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent - History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil - History of Interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis - History of clinically significant, intercurrent lung-specific illnesses including, but not limited to: - Underlying pulmonary disorder - Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at screening (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis etc.), and prior pneumonectomy - History of cardiac disease - Untreated brain or meningeal metastases - History of another malignancy within the last 3 years prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) Overall Survival (OS) Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Duration Of Response (DoR) as assessed by BICR Disease Control (DC) as assessed by BICR Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13 Change from baseline in the remaining EORCT QLQ-C30 domains | — |
Countries
Belgium, Brazil, China, Germany, Greece, Japan, Portugal, South Korea, Spain, Taiwan, United States of America
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed