Status and phase
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About
The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts.
Full description
The study is a prospective multi-cohort clinical study. The study is divided into two phases, Phase Ia and Phase Ib. In Phase Ia, a dose escalation portion was conducted using a 3+3 dose-escalation design, with a preference for enrolling subjects with advanced non-small cell lung cancer and melanoma. Phase Ib represents the cohort expansion phase, comprising seven cohorts. All the research data were collected follow the SAP.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
a) Subjects who have previously received treatment for central nervous system metastases must meet all of the following criteria to be eligible for this study:
Completed treatment for central nervous system metastases (e.g., whole-brain radiation therapy, stereotactic radiosurgery, or equivalent treatment) at least 14 days before the first dose of the investigational drug.
Post-treatment repeat imaging confirmed no evidence of new brain metastases or enlargement of existing brain metastatic lesions (with an interval of ≥4 weeks and using the same imaging technique as the pre-treatment head imaging).
No requirement for steroid treatment and stable symptoms for at least 14 days before the first dose of the investigational drug.
b) Subjects who have not previously received treatment for central nervous system metastases must meet all of the following criteria to be eligible for this study:
No symptoms related to central nervous system metastases.
Investigator assessment that immediate treatment for central nervous system metastases is not required.
A maximum of three central nervous system metastatic lesions, with each lesion having a maximum diameter of ≤5 mm.
Significant cardiovascular and cerebrovascular diseases, including:
Requiring medical intervention due to ventricular arrhythmias or other uncontrolled arrhythmias, such as treatment with anti-arrhythmic drugs.
Severe conduction disturbances (e.g., third-degree atrioventricular block).
HR-corrected QT interval (QTc interval, calculated using the Fridericia method) ≥480 ms.
Uncontrolled hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg), a history of hypertensive crisis, or hypertensive encephalopathy.
A history of myocarditis.
Symptomatic congestive heart failure (New York Heart Association functional classes II-IV) or cardiac ultrasound findings indicating left ventricular ejection fraction (LVEF) <50%.
Any arterial thrombosis, embolism, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to the first dose of the investigational drug.
History of deep venous thrombosis or any other serious thromboembolic event within the 3 months before enrollment (implantable venous access port or catheter-related thrombosis, or superficial venous thrombosis are not considered "serious" thromboembolic events).
Primary purpose
Allocation
Interventional model
Masking
430 participants in 11 patient groups
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Central trial contact
Nong Yang, MD; Yongchang Zhang, MD
Data sourced from clinicaltrials.gov
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