Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT04492033
Eligibility Criteria:
Key Inclusion Criteria:
* P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
* P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma)
* P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent
* Patients aged 19 years or older
* At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1.
* Life expectancy ≥ 12 weeks
* ECOG performance status 0 or 1
* Women of childbearing potential must have a negative pregnancy test outcome
* Patients must provide written informed consent to voluntary participation in this study
Key Exclusion Criteria:
* History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel
* Less than 4 weeks have elapsed since a surgery
* History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina
* Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy
* Severe infections or major and unhealed injury (active ulcer, untreated fracture)
* Symptomatic or uncontrolled central nervous system (CNS) metastasis
* Pregnant or lactating women or patients planning to become pregnant during the study
* Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment
* Administration of antiplatelets or anticoagulants within 2 weeks prior to screening
* Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
* HIV or other severe diseases that warrant the exclusion from this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04492033
Study Brief:
Protocol Section:
NCT04492033