drugset / Trial / NCT05804864

A Study of KM501 in Patients With Solid Tumors

NCT05804864 ↗

Phase 1 Not yet recruiting 96 enrolled Xuanzhu Biopharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

A single-arm, open, multicenter Phase I study to evaluate the safety, tolerability, pharmacokinetic profile, and efficacy of the KM501 double-antibody ADC in subjects with advanced solid tumors that express, amplify, or mutate HER2

Timeline

Start
2023-04
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject KM501 Unknown 0.1 mg/kg —
Subject KM501 Unknown 0.3 mg/kg —
Subject KM501 Unknown 0.6 mg/kg —
Subject KM501 Unknown 1.2 mg/kg —
Subject KM501 Unknown 1.8 mg/kg —
Subject KM501 Unknown 2.4 mg/kg —

Indications