Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors

Phase 3 Completed 754 enrolled Fujian Shengdi Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

To evaluate the efficacy and safety of HR20013 for injection for prevention of chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy.

Timeline

Start: 2022-09-21
Primary completion: 2023-06-19
Completion: 2023-08-30

Outcome

Met primary endpoint

paper demonstrating that HR20013 + DEX was noninferior to FAPR + PALO + DEX. PMID 39621965 ↗

Publications

Zhou H, Zhao Y, Zhang M, Yao J, Leng S, Li X, Lin L, Chen J, Zhang S, Qin X, Qin Z, Yi T, Wang R, Li X, Yu Y, Wang Z, Zheng Q, Mei J, Zang A, Li N, Cao F, Cao K, Li W, Lu Y, Lin D, Zhou Y, Yang R, Fang W, Zhou N, Yang Y, Zhang Y, Chen G, Zhou T, Yang X, Wang H, Wang Y, Huang Y, Zhang L. Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT. J Clin Oncol. 2025 Mar 20;43(9):1123-1136. doi: 10.1200/JCO-24-01308. Epub 2024 Dec 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fosaprepitant	Other / unclassified	—	—
Subject	HR20013	Other / unclassified	—	Intravenous
Comparator	Palonosetron	Other / unclassified	—	—
Background	Dexamethasone	Small molecule	—	Oral

Indications

No indication recorded.