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drugset / Trial / NCT05309512

Clinical Study of KN052 in Chinese Subjects With Advanced Solid Tumors

NCT05309512 ↗

Phase 1 Terminated 15 enrolled Jiangsu Alphamab Biopharmaceuticals Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).

Timeline

Start
2022-05-27
Primary completion
2023-11-14
Completion
2023-11-14

Outcome

Outcome not reported

Stopped (Business): “Based on the differentiated R\&D strategy, the sponsor applies for the termination of the project.”

Drugs

EvaluationDrugModalityDoseRoute
Subject KN052 Unknown 0.01 mg/kg Intravenous
Subject KN052 Unknown 0.1 mg/kg Intravenous
Subject KN052 Unknown 0.3 mg/kg Intravenous
Subject KN052 Unknown 1 mg/kg Intravenous
Subject KN052 Unknown 2 mg/kg Intravenous
Subject KN052 Unknown 4 mg/kg Intravenous
Subject KN052 Unknown 6 mg/kg Intravenous
Subject KN052 Unknown 9 mg/kg Intravenous

Indications

neoplasm