Study of HR20013 for Injection in Patients With Malignant Solid Tumors

NCT05465681 | Completed Phase 1

• 1 other identifier: HR20013-102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (1)

HR20013 for injection+dexamethasone

EXPERIMENTAL

Drug: HR20013 for injection；dexamethason

Interventions

HR20013 for injection；dexamethason DRUG

HR20013 for injection；Drug for preventing nausea and vomiting caused by chemotherapy. dexamethasone: Drug for preventing nausea and vomiting caused by chemotherapy

HR20013 for injection+dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• Zhao Y, Ma Y, Yin T, Qin Z, Liu L, Kong G, Zhang R, Huang Y, Zhang L, Zhao H. Pharmacokinetics, safety, and efficacy of mixed formulation of fosrolapitant and palonosetron (HR20013) in combination with dexamethasone in patients with solid tumors scheduled for highly emetogenic cisplatin-based chemotherapy: a phase I trial. BMC Med. 2025 Aug 27;23(1):501. doi: 10.1186/s12916-025-04314-5.

  PMID: 40866861 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR20013 for injection combined with dexamethasone

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: August 30, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: April 12, 2023

Record last verified: 2022-06

Locations

CN (1)