Clinical trial · Interventional
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
NCT05465681CI-TRIAL-00065566completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HR20013 for injection;dexamethason | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HR20013 for injection+dexamethasone
- interventionNames
- Drug: HR20013 for injection;dexamethason
Primary outcomes (5)
- measure
- AUC0-t :area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
- timeFrame
- 0 to 504 hours
- measure
- AUC0-∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity
- timeFrame
- 0 to 504 hours
- measure
- Cmax:observed maximum plasma concentration
- timeFrame
- 0 to 504 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhao 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