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:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT06636435
Eligibility Criteria:
Inclusion Criteria:(Part 1-4)
* Patients who provide voluntary written informed consent to participate in the study
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of≤1
* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (creatinine: ≤ ULN ×1.5)
* Patients who meet the following laboratory criteria of bone marrow function as evidenced by laboratory data obtained within 7 days before enrollment: Neutrophil count;≥1500/μL, Platelet count; ≥75000/μL, Hemoglobin;≥9.0 g/dL.
* Patients having Solid Tumors with no standard therapy available or refractory or intolerable to standard therapy (Part2, 3)
* Patients with Child-Pugh A or B (Part2, 3)
* Patients with Malignant Melanoma who are refractory or intolerant to standard therapy (Part 4)
Inclusion Criteria:(Part 5)
* Patients who provide voluntary written informed consent to participate in the study from both the subject (if aged 16 years or older) and their legal representatives
* Japanese patients aged 2 years or older and under 20 years at the time of informed consent
* Patients with a Lansky Performance Status (LPS) of ≥70 (for patients aged 15 years or younger) or a Karnofsky Performance Status (KPS) of ≥70 (for patients aged 16 years or older)
* Patients with preserved renal function as evidenced by laboratory data obtained within 7 days before enrollment (eGFR ≥60 mL/min/1.73 m²)
* Pediatric patients with cancers with no standard therapy available or refractory or intolerable to the standard therapy
Exclusion criteria: (Part1-5)
* Patients who have undergone major surgery within 28 days before enrollment
* Patients who have received anticancer treatment with surgical therapy, radiation therapy, and/or drug therapy within 14 days before enrollment
* Patients who have received anticancer treatment with immune checkpoint inhibitor, etc. within 28 days before enrollment
* Patients with Grade 2 or higher concurrent disease or prior therapy-related toxicity
* Patients who have received any other investigational product within 28 days before enrollment
* Patients with current or previous inadequately controlled or clinically significant cardiac disease
* Patients who, in the opinion of the investigator or subinvestigator, is not appropriate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06636435
Study Brief:
Protocol Section:
NCT06636435