Clinical Trial

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors

Not Yet Recruiting Phase 1
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Summary
This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors. The study consists of a dose escalation phase and a dose expansion phase. In the dose escalation phase, a 3+3 dose escalation design will be used to evaluate multiple dose levels. The dose expansion phase will enroll patients into expansion cohorts at selected dose levels to further evaluate safety and preliminary efficacy.
Trial Details
NCT Number NCT07695142
Lead Sponsor Haisco Pharmaceutical Group Co., Ltd.
Conditions Advanced Solid Tumor (Phase 1)
Enrollment 275 participants
Start Date 2026-07-09
Primary Completion 2028-12-30 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-10