Study of HR20013 for Injection in Patients With Malignant Solid Tumors

Phase 1 Completed 24 enrolled Fujian Shengdi Pharmaceutical Co., Ltd.

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start: 2022-08-30
Primary completion: 2023-01-13
Completion: 2023-01-13

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	3.75 mg	Oral
Subject	Fosrolapitant	Small molecule	—	Intravenous
Subject	Palonosetron	Other / unclassified	—	Intravenous

Indications

No indication recorded.