^
6ms
New P2 trial
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HS-10365
12ms
Phase Ⅰ/Ⅱ Study of the HS-10365 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=306, Recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd. | Phase classification: P1 --> P1/2 | N=48 --> 306 | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Apr 2024
Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Metastases
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PD-L1 (Programmed death ligand 1) • RET (Ret Proto-Oncogene)
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HS-10365
1year
HS-10365, a highly potent and selective RET tyrosine kinase inhibitor, demonstrates robust activity in RET fusion positive NSCLC patients (AACR 2023)
Background: Activating RET alterations drive oncogenic signaling in lung, thyroid, and other solid tumors.Until recently, only two RET tyrosine kinase inhibitor (TKI), BLU-667 and LOXO-292, had received approval for advanced NSCLC by FDA and NMPA. HS-10365 showed a manageable safety profile and favorable PK properties. The promising antitumor activity with expectable response time was observed in RET fusion+ NSCLC pts, no matter with or without previous treatments.
Clinical
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RET (Ret Proto-Oncogene) • KIF5B (Kinesin Family Member 5B) • CCDC6 (Coiled-Coil Domain Containing 6)
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RET fusion • RET mutation • RET positive
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Retevmo (selpercatinib) • Gavreto (pralsetinib) • HS-10365
over2years
Phase 1 Study of the HS-10365 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=48, Recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.
New P1 trial
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RET (Ret Proto-Oncogene)
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HS-10365