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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT03642834
Eligibility Criteria:
Inclusion Criteria:
* 18 Years and older.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
* At least one evaluable disease according to RECIST1.1.
* Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.
* Adequate bone marrow, liver, renal, and cardiovascular function.
Exclusion Criteria:
* Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors.
* Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105.
* Major surgery within 6 weeks of the first dose of ICP-105.
* Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105.
* Crohn's disease with symptoms and systemic treatment.
* Central nervous system (CNS) metastasis.
* Current clinically significant cardiovascular disease including:
* Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) \< 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc\>470ms (female) QTc\>450ms (male).
* Known active bleeding within 2 months of screening or 6 months of bleeding history.
* Lung function impairment by pleural effusion or ascites, any history of interstitial pneumonia, deep vein thrombosis, pulmonary embolism.
* Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection.
* Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).
* Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03642834
Study Brief:
Protocol Section:
NCT03642834