Study of HR20013 for Injection in Patients With Malignant Solid Tumors

Inclusion criteria

• 18 years of age or older, of either gender
• Has a diagnosed malignant tumor
• has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
• Predicted life expectancy of ≥ 3 months
• Has a performance status (ECOG scale) of 0 to 1
• Adequate bone marrow, kidney, and liver function
• Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
• Able and willing to provide a written informed consent

Exclusion criteria

• Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
• Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
• Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
• Subjects receiving palonosetron hydrochloride within 14 days before enrollment
• Subjects who previously received NK-1 receptor antagonists within 14 days prior to enrollment
• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with poor blood pressure control after medication
• Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
• Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours prior to the start of cisplatin
• Participated in clinical trials of other drugs (received experimental drugs)
• The investigators determined that other conditions were inappropriate for participation in this clinical trial