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CompletedNCT05465681Updated Apr 12, 2023

Study of HR20013 for Injection in Patients With Malignant Solid Tumors

A Phase 1 interventional study of HR20013 for injection；dexamethason in Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

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03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's enrollment of 24 is below the median of 107 across 935 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    HR20013 for injection+dexamethasone

    Drug: HR20013 for injection；dexamethason

Interventions

  • DrugHR20013 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

06

What researchers measure

Primary outcomes

  1. AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration

    Time frame: 0 to 504 hours

  2. AUC0-∞：Area Under the Plasma Concentration-time Curve From Time 0 to Infinity

    Time frame: 0 to 504 hours

  3. Cmax：observed maximum plasma concentration

    Time frame: 0 to 504 hours

  4. Tmax：observed time to reach Cmax

    Time frame: 0 to 504 hours

  5. T1/2z：apparent terminal half-life

    Time frame: 0 to 504 hours

Secondary outcomes

  1. 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

    Time frame: 0 to 504 hours

  2. Complete response

    Time frame: 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

  3. No significant nausea (maximum nausea on a visual analogue scale<25 mm)

    Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours

  4. No nausea (maximum nausea on a visual analogue scale<5 mm)

    Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours

  5. No emetic

    Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours

  6. No rescue medication

    Time frame: During the Acute Phase, the Delayed phase, the overall phase, >120-168 hours and 0-168 hours

  7. Time to treatment failure

    Time frame: During 0-168 hours

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510000, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05465681
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 20, 2022
Start date
Aug 30, 2022
Primary completion
Jan 13, 2023
Completion
Jan 13, 2023
Last update
Apr 12, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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