Study of HR20013 for Injection in Patients With Malignant Solid Tumors

Study Overview
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Brief Summary
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To evaluate the safety and pharmacokinetics of single-dose HR20013 for injection combined with dexamethasone in patients with malignant solid tumors receiving cisplatin-based chemotherapy.

Official Title
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A Phase I Clinical Study of Safety and Pharmacokinetics of Single-dose HR20013 for Injection Combined With Dexamethasone in Patients With Malignant Solid Tumors Receiving Cisplatin-based Chemotherapy

Conditions
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Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Intervention / Treatment
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* Drug: HR20013 for injection；dexamethason


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: HR20013 for injection combined with dexamethasone
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR20013 for injection+dexamethasone<br> | Drug: HR20013 for injection；dexamethason<br>* HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy. dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration |  | 0 to 504 hours | 
| AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity |  | 0 to 504 hours | 
| Cmax：observed maximum plasma concentration |  | 0 to 504 hours | 
| Tmax：observed time to reach Cmax |  | 0 to 504 hours | 
| T1/2z：apparent terminal half-life |  | 0 to 504 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0 | The number of participants with injection site reaction and treatment-related adverse events as assessed by CTCAE v5.0 | 0 to 504 hours | 
| Complete response |  | During the Acute Phase [0-24 hours after the start of cisplatin administration], the Delayed (>24-120 hours) phase, the overall (0-120 hours) phase, >120-168 hours and 0-168 hours | 
| No significant nausea (maximum nausea on a visual analogue scale<25 mm) |  | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours | 
| No nausea (maximum nausea on a visual analogue scale<5 mm) |  | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours | 
| No emetic |  | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours | 
| No rescue medication |  | During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours | 
| Time to treatment failure |  | During 0-168 hours |