Study of HR20013 for Injection in Patients With Malignant Solid Tumors

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

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.

Study Overview

• Status: Completed
• Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy
• Intervention / Treatment: Drug: HR20013 for injection；dexamethason

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: HR20013-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No